| VITROS Performance Verifier I recall (Z-1372-2024) | Ortho-Clinical Diagnostics | 2024-03-22 |
| VITROS Performance Verifier II recall (Z-1373-2024) | Ortho-Clinical Diagnostics | 2024-03-22 |
| VITROS Immunodiagnostic Products Troponin I ES Reagent Pack recall (Z-2357-2023) | ORTHO-CLINICAL DIAGNOSTICS | 2023-08-08 |
| VITROS Immunodiagnostic Products Troponin I ES Calibrators recall (Z-2358-2023) | ORTHO-CLINICAL DIAGNOSTICS | 2023-08-08 |
| VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry recall (Z-2129-2023) | Ortho-Clinical Diagnostics | 2023-07-11 |
| enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 recall (Z-2143-2016) | Ortho-Clinical Diagnostics | 2016-07-08 |
| VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409 recall (Z-1071-2016) | Ortho-Clinical Diagnostics | 2016-03-08 |
| VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758 recall (Z-1072-2016) | Ortho-Clinical Diagnostics | 2016-03-08 |
| VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 1075 recall (Z-1073-2016) | Ortho-Clinical Diagnostics | 2016-03-08 |
| VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 1075 recall (Z-1074-2016) | Ortho-Clinical Diagnostics | 2016-03-08 |
| VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10 recall (Z-1075-2016) | Ortho-Clinical Diagnostics | 2016-03-08 |
| VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 1075 recall (Z-0640-2016) | Ortho-Clinical Diagnostics | 2016-01-13 |
| VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 1075 recall (Z-0641-2016) | Ortho-Clinical Diagnostics | 2016-01-13 |
| VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 1075 recall (Z-0642-2016) | Ortho-Clinical Diagnostics | 2016-01-13 |
| VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10 recall (Z-0643-2016) | Ortho-Clinical Diagnostics | 2016-01-13 |
| VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identif recall (Z-0231-2016) | Ortho-Clinical Diagnostics | 2015-11-05 |
| VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique recall (Z-0202-2016) | Ortho-Clinical Diagnostics | 2015-11-02 |
| VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identif recall (Z-2544-2015) | Ortho-Clinical Diagnostics | 2015-09-02 |
| VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and p recall (Z-1742-2015) | Ortho-Clinical Diagnostics | 2015-06-09 |
| VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and p recall (Z-1743-2015) | Ortho-Clinical Diagnostics | 2015-06-09 |
| enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all recall (Z-1724-2015) | Ortho-Clinical Diagnostics | 2015-06-08 |
| VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and recall (Z-1728-2015) | Ortho-Clinical Diagnostics | 2015-06-08 |
| Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automate recall (Z-1729-2015) | Ortho-Clinical Diagnostics | 2015-06-08 |
| VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Ident recall (Z-1707-2015) | ORTHO-CLINICAL DIAGNOSTICS | 2015-06-04 |
| Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, G recall (Z-1521-2015) | Ortho-Clinical Diagnostics | 2015-04-25 |
| VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITRO recall (Z-1263-2015) | Ortho-Clinical Diagnostics | 2015-03-11 |
| VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems ( recall (Z-1004-2015) | Ortho-Clinical Diagnostics | 2015-01-20 |
| VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagno recall (Z-0967-2015) | Ortho-Clinical Diagnostics | 2015-01-14 |
| VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, recall (Z-0968-2015) | Ortho-Clinical Diagnostics | 2015-01-14 |
| VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. recall (Z-0969-2015) | Ortho-Clinical Diagnostics | 2015-01-14 |
| VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. recall (Z-0848-2015) | Ortho-Clinical Diagnostics | 2014-12-22 |
| VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 680 recall (Z-0077-2015) | Ortho-Clinical Diagnostics | 2014-10-16 |
| VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quanti recall (Z-0078-2015) | Ortho-Clinical Diagnostics | 2014-10-16 |
| VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in recall (Z-0007-2015) | Ortho-Clinical Diagnostics | 2014-10-02 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection recall (Z-2671-2014) | ORTHO-CLINICAL DIAGNOSTICS | 2014-09-19 |
| VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product recall (Z-2214-2014) | Ortho-Clinical Diagnostics | 2014-08-13 |
| VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS CA recall (Z-2183-2014) | ORTHO-CLINICAL DIAGNOSTICS | 2014-08-11 |
| VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantit recall (Z-2139-2014) | Ortho-Clinical Diagnostics | 2014-08-01 |
| VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chem recall (Z-2140-2014) | Ortho-Clinical Diagnostics | 2014-08-01 |
| VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, recall (Z-2141-2014) | Ortho-Clinical Diagnostics | 2014-08-01 |
| VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- F recall (Z-1804-2014) | Ortho-Clinical Diagnostics | 2014-06-16 |
| VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For recall (Z-1805-2014) | Ortho-Clinical Diagnostics | 2014-06-16 |
| enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For recall (Z-1741-2014) | Ortho-Clinical Diagnostics | 2014-06-10 |
| VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic recall (Z-1734-2014) | Ortho-Clinical Diagnostics | 2014-06-09 |
| VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic recall (Z-1735-2014) | Ortho-Clinical Diagnostics | 2014-06-09 |
| VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Number recall (Z-1736-2014) | Ortho-Clinical Diagnostics | 2014-06-09 |
| enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative recall (Z-1738-2014) | Ortho-Clinical Diagnostics | 2014-06-09 |
| enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument M recall (Z-1677-2014) | Ortho-Clinical Diagnostics | 2014-06-02 |
| VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human se recall (Z-1648-2014) | Ortho-Clinical Diagnostics | 2014-05-21 |
| VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinica recall (Z-1519-2014) | Ortho-Clinical Diagnostics | 2014-04-28 |
| VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD recall (Z-1520-2014) | Ortho-Clinical Diagnostics | 2014-04-28 |
| VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF recall (Z-1490-2014) | Ortho-Clinical Diagnostics | 2014-04-23 |
| VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, In recall (Z-1470-2014) | Ortho-Clinical Diagnostics | 2014-04-17 |
| VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT recall (Z-1226-2014) | Ortho-Clinical Diagnostics | 2014-03-19 |
| VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055 recall (Z-1193-2014) | Ortho-Clinical Diagnostics | 2014-03-12 |
| VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Techn recall (Z-1087-2014) | Ortho-Clinical Diagnostics | 2014-02-25 |
| VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 100 recall (Z-1088-2014) | Ortho-Clinical Diagnostics | 2014-02-25 |
| VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems recall (Z-0968-2014) | Ortho-Clinical Diagnostics | 2014-02-10 |
| enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS recall (Z-0941-2014) | Ortho-Clinical Diagnostics | 2014-02-09 |
| enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry recall (Z-0942-2014) | Ortho-Clinical Diagnostics | 2014-02-09 |
| VITROS Chemistry Products COCM Reagent recall (Z-0817-2014) | Ortho-Clinical Diagnostics | 2014-01-23 |
| VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs recall (Z-0557-2014) | Ortho-Clinical Diagnostics | 2013-12-20 |
| VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagn recall (Z-0525-2014) | Ortho-Clinical Diagnostics | 2013-12-17 |
| VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemi recall (Z-0292-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemis recall (Z-0293-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Sl recall (Z-0294-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Sl recall (Z-0295-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP recall (Z-0296-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 a recall (Z-0297-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 a recall (Z-0298-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VI recall (Z-0299-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 a recall (Z-0300-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 81022 recall (Z-0301-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VIT recall (Z-0302-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 an recall (Z-0303-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 V recall (Z-0304-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and recall (Z-0305-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 recall (Z-0306-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382 recall (Z-0307-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 V recall (Z-0308-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VIT recall (Z-0309-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VI recall (Z-0310-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 V recall (Z-0311-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 V recall (Z-0312-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and recall (Z-0313-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VI recall (Z-0314-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 an recall (Z-0315-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and recall (Z-0316-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 a recall (Z-0317-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and recall (Z-0318-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VI recall (Z-0319-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 V recall (Z-0320-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VI recall (Z-0321-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VI recall (Z-0322-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VI recall (Z-0323-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 V recall (Z-0324-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 a recall (Z-0325-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 a recall (Z-0326-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VI recall (Z-0327-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 V recall (Z-0328-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |