| cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply recall (Z-1476-2026) | Roche Diagnostics Operations, Inc. | 2026-02-27 |
| The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidi recall (Z-1009-2026) | Roche Diagnostics Operations, Inc. | 2026-01-02 |
| cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on coba recall (Z-0489-2025) | Roche Diagnostics Operations, Inc. | 2024-11-19 |
| Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test recall (Z-3187-2024) | Roche Diagnostics Operations, Inc. | 2024-09-20 |
| Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Num recall (Z-0352-2024) | Roche Diagnostics Operations, Inc. | 2023-11-20 |
| cobas infinity central lab, Material Number 07154003001 recall (Z-0952-2023) | Roche Diagnostics Operations, Inc. | 2023-01-12 |
| 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodi recall (Z-1098-2021) | Roche Diagnostics Operations, Inc. | 2021-02-08 |
| CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantit recall (Z-0803-2021) | Roche Diagnostics Operations, Inc. | 2021-01-07 |
| CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for peopl recall (Z-0804-2021) | Roche Diagnostics Operations, Inc. | 2021-01-07 |
| Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for m recall (Z-1444-2020) | Roche Diagnostics Operations, Inc. | 2020-03-05 |
| Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: recall (Z-0152-2020) | Roche Diagnostics Operations, Inc. | 2019-10-16 |
| Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test f recall (Z-0153-2020) | Roche Diagnostics Operations, Inc. | 2019-10-16 |
| Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 recall (Z-2361-2019) | Roche Diagnostics Operations, Inc. | 2019-08-23 |
| Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 recall (Z-2362-2019) | Roche Diagnostics Operations, Inc. | 2019-08-23 |
| Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Qua recall (Z-1092-2017) | Roche Diagnostics Operations, Inc. | 2017-01-24 |
| Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whol recall (Z-1077-2017) | Roche Diagnostics Operations, Inc. | 2017-01-23 |
| Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640 recall (Z-0395-2017) | Roche Diagnostics Operations, Inc. | 2016-11-11 |
| COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 0 recall (Z-0396-2017) | Roche Diagnostics Operations, Inc. | 2016-11-11 |
| Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Pro recall (Z-0387-2017) | Roche Diagnostics Operations, Inc. | 2016-11-10 |
| ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modu recall (Z-2304-2016) | Roche Diagnostics Operations, Inc. | 2016-08-01 |
| Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitorin recall (Z-1172-2016) | Roche Diagnostics Operations, Inc. | 2016-03-14 |
| Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-cap recall (Z-0297-2016) | Roche Diagnostics Operations, Inc. | 2015-11-18 |
| cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system recall (Z-2446-2015) | Roche Diagnostics Operations, Inc. | 2015-08-21 |
| cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system recall (Z-2447-2015) | Roche Diagnostics Operations, Inc. | 2015-08-21 |
| S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrol recall (Z-2330-2015) | Roche Diagnostics Operations, Inc. | 2015-08-05 |
| Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi s recall (Z-1920-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vit recall (Z-1921-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determin recall (Z-1922-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas recall (Z-1923-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Chol recall (Z-1924-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 an recall (Z-1925-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hit recall (Z-1926-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for recall (Z-1927-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intende recall (Z-1928-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in hu recall (Z-1929-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of trigly recall (Z-1930-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in huma recall (Z-1931-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |
| Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, coba recall (Z-1622-2015) | Roche Diagnostics Operations, Inc. | 2015-05-15 |
| Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer recall (Z-1041-2015) | Roche Diagnostics Operations, Inc. | 2015-02-02 |
| ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or recall (Z-0883-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injecti recall (Z-0884-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or inject recall (Z-0885-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injecti recall (Z-0886-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injecti recall (Z-0887-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or inject recall (Z-0888-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or i recall (Z-0889-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or i recall (Z-0890-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or recall (Z-0891-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or i recall (Z-0892-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or i recall (Z-0893-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or recall (Z-0894-2015) | Roche Diagnostics Operations, Inc. | 2014-12-30 |
| ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Produc recall (Z-0146-2015) | Roche Diagnostics Operations, Inc. | 2014-10-29 |
| Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Om recall (Z-0064-2015) | Roche Diagnostics Operations, Inc. | 2014-10-10 |
| Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, r recall (Z-2563-2014) | Roche Diagnostics Operations, Inc. | 2014-09-01 |
| Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-0 recall (Z-1790-2014) | Roche Diagnostics Operations, Inc. | 2014-06-14 |
| cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No recall (Z-1791-2014) | Roche Diagnostics Operations, Inc. | 2014-06-14 |
| cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 0 recall (Z-1792-2014) | Roche Diagnostics Operations, Inc. | 2014-06-14 |
| ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count s recall (Z-1616-2014) | Roche Diagnostics Operations, Inc. | 2014-05-13 |
| Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemist recall (Z-1449-2014) | Roche Diagnostics Operations, Inc. | 2014-04-10 |
| Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Numbe recall (Z-1315-2014) | Roche Diagnostics Operations, Inc. | 2014-04-02 |
| MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated is recall (Z-0536-2014) | Roche Diagnostics Operations, Inc. | 2013-12-18 |
| ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ recall (Z-0385-2014) | Roche Diagnostics Operations, Inc. | 2013-11-22 |
| COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28 recall (Z-0168-2014) | Roche Diagnostics Operations, Inc. | 2013-11-05 |
| ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glu recall (Z-2109-2013) | Roche Diagnostics Operations, Inc. | 2013-08-28 |
| B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro recall (Z-1727-2013) | Roche Diagnostics Operations, Inc. | 2013-07-12 |
| CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS Sys recall (Z-1581-2013) | Roche Diagnostics Operations, Inc. | 2013-06-24 |
| CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek recall (Z-1582-2013) | Roche Diagnostics Operations, Inc. | 2013-06-24 |
| CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare p recall (Z-1583-2013) | Roche Diagnostics Operations, Inc. | 2013-06-24 |
| CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional heal recall (Z-1584-2013) | Roche Diagnostics Operations, Inc. | 2013-06-24 |
| Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the co recall (Z-1368-2013) | Roche Diagnostics Operations, Inc. | 2013-05-23 |
| ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-C recall (Z-1113-2013) | Roche Diagnostics Operations, Inc. | 2013-04-15 |
| CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCH recall (Z-1114-2013) | Roche Diagnostics Operations, Inc. | 2013-04-15 |
| Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 0523273 recall (Z-1028-2013) | Roche Diagnostics Operations, Inc. | 2013-04-01 |
| Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer. recall (Z-0696-2013) | Roche Diagnostics Operations, Inc. | 2013-01-18 |
| Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole bloo recall (Z-0522-2013) | Roche Diagnostics Operations, Inc. | 2012-12-13 |
| Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 recall (Z-0473-2013) | Roche Diagnostics Operations, Inc. | 2012-12-04 |
| Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac trop recall (Z-1387-2012) | Roche Diagnostics Operations, Inc. | 2012-04-11 |
| Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac recall (Z-1388-2012) | Roche Diagnostics Operations, Inc. | 2012-04-11 |
| ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied to recall (Z-1386-2012) | Roche Diagnostics Operations, Inc. | 2012-04-09 |
| Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the recall (Z-1218-2012) | Roche Diagnostics Operations, Inc. | 2012-03-16 |
| cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of per recall (Z-0310-2012) | Roche Diagnostics Operations, Inc. | 2011-11-30 |
| Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyz recall (Z-0311-2012) | Roche Diagnostics Operations, Inc. | 2011-11-30 |
| MagNA Pure LC 1.0 (software version 3.0.11). Roche Diagnostics Operations, Inc. An automat recall (Z-3077-2011) | Roche Diagnostics Operations, Inc. | 2011-08-29 |
| MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations, Inc. recall (Z-3078-2011) | Roche Diagnostics Operations, Inc. | 2011-08-29 |
| ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GM recall (Z-2570-2011) | Roche Diagnostics Operations, Inc. | 2011-06-21 |
| Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Asse recall (Z-1998-2011) | Roche Diagnostics Operations, Inc. | 2011-04-15 |
| Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas recall (Z-1823-2011) | Roche Diagnostics Operations, Inc. | 2011-03-25 |
| Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagn recall (Z-1824-2011) | Roche Diagnostics Operations, Inc. | 2011-03-25 |
| Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Dia recall (Z-1679-2011) | Roche Diagnostics Operations, Inc. | 2011-03-16 |
| Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, R recall (Z-1680-2011) | Roche Diagnostics Operations, Inc. | 2011-03-16 |
| MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, recall (Z-1651-2011) | Roche Diagnostics Operations, Inc. | 2011-03-14 |
| Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indian recall (Z-1652-2011) | Roche Diagnostics Operations, Inc. | 2011-03-14 |
| Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The Fa recall (Z-1653-2011) | Roche Diagnostics Operations, Inc. | 2011-03-14 |
| ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roc recall (Z-2386-2010) | Roche Diagnostics Operations, Inc. | 2010-09-08 |
| Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modu recall (Z-0970-2010) | Roche Diagnostics Operations, Inc. | 2010-03-08 |
| Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Cat recall (Z-0971-2010) | Roche Diagnostics Operations, Inc. | 2010-03-08 |
| Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog recall (Z-0972-2010) | Roche Diagnostics Operations, Inc. | 2010-03-08 |
| Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianap recall (Z-2002-2009) | Roche Diagnostics Operations, inc. | 2009-09-03 |
| Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Cata recall (Z-2003-2009) | Roche Diagnostics Operations, inc. | 2009-09-03 |
| Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN recall (Z-2004-2009) | Roche Diagnostics Operations, inc. | 2009-09-03 |