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Bio-Rad Laboratories, Inc.

61 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assa recall (Z-2515-2025)Bio-Rad Laboratories, Inc.2025-09-04
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack recall (Z-1572-2023)Bio-Rad Laboratories, Inc.2023-05-10
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD recall (Z-1377-2023)Bio-Rad Laboratories, Inc.2023-04-12
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD recall (Z-1378-2023)Bio-Rad Laboratories, Inc.2023-04-12
CMV IgM EIA, in vitro diagnostic. recall (Z-0342-2023)Bio-Rad Laboratories, Inc.2022-12-06
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Man recall (Z-0807-2016)Bio-Rad Laboratories, Inc.2016-02-13
D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system recall (Z-0695-2016)Bio-Rad Laboratories, Inc.2016-01-27
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare recall (Z-1840-2015)Bio-Rad Laboratories, Inc.2015-06-25
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 recall (Z-1537-2014)Bio-Rad Laboratories, Inc.2014-05-02
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laborator recall (Z-1299-2014)Bio-Rad Laboratories, Inc.2014-03-27
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio recall (Z-0965-2014)Bio-Rad Laboratories, Inc.2014-02-10
Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended recall (Z-1330-2013)Bio-rad Laboratories, Inc.2013-05-16
VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determinatio recall (Z-0399-2012)Bio-Rad Laboratories, Inc.2012-01-11
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A recall (Z-0017-2012)Bio-Rad Laboratories, Inc.2011-10-07
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. P recall (Z-0018-2012)Bio-Rad Laboratories, Inc.2011-10-07
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Pe recall (Z-0019-2012)Bio-Rad Laboratories, Inc.2011-10-07
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United Stat recall (Z-0020-2012)Bio-Rad Laboratories, Inc.2011-10-07
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United Stat recall (Z-0021-2012)Bio-Rad Laboratories, Inc.2011-10-07
VARIANT II TURBO Hemoglobin A1c Program Buffer B, Made in United States. Bio-Rad Laborator recall (Z-0022-2012)Bio-Rad Laboratories, Inc.2011-10-07
VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determ recall (Z-0023-2012)Bio-Rad Laboratories, Inc.2011-10-07
VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determ recall (Z-0024-2012)Bio-Rad Laboratories, Inc.2011-10-07
VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United States. recall (Z-0025-2012)Bio-Rad Laboratories, Inc.2011-10-07
VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad La recall (Z-0026-2012)Bio-Rad Laboratories, Inc.2011-10-07
VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the determinati recall (Z-0027-2012)Bio-Rad Laboratories, Inc.2011-10-07
VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Ki recall (Z-3159-2011)Bio-Rad Laboratories, Inc.2011-09-06
D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include E recall (Z-2889-2011)Bio-Rad Laboratories Inc2011-07-27
VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-300 recall (Z-1984-2011)Bio-Rad Laboratories Inc2011-04-14
Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. recall (Z-1932-2011)Bio-Rad Laboratories Inc2011-04-11
Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A recall (Z-1898-2011)Bio-Rad Laboratories Inc2011-04-06
The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Ra recall (Z-1846-2011)Bio-Rad Laboratories Inc2011-03-29
PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is an recall (Z-1726-2011)Bio-Rad Laboratories, Inc.2011-03-18
Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, Catalog No. 96DS, Distributed recall (Z-1647-2011)Bio-Rad Laboratories Inc2011-03-14
Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests, Catalog No. 576DS, Distribute recall (Z-1648-2011)Bio-Rad Laboratories Inc2011-03-14
Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 a recall (Z-1562-2011)Bio-Rad Laboratories Inc2011-03-04
DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laborato recall (Z-1478-2011)Bio-Rad Laboratories Inc2011-03-02
Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Ma recall (Z-1479-2011)Bio-Rad Laboratories Inc2011-03-02
PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad recall (Z-1495-2011)Bio-Rad Laboratories Inc2011-03-02
Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog N recall (Z-1342-2011)Bio-Rad Laboratories Inc2011-02-17
Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program R recall (Z-1259-2011)Bio-Rad Laboratories Inc2011-02-15
Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Labora recall (Z-0608-2011)Bio-Rad Laboratories Inc2010-12-13
Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed an recall (Z-0612-2011)Bio-Rad Laboratories Inc2010-12-13
Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactur recall (Z-0613-2011)Bio-Rad Laboratories Inc2010-12-13
Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured b recall (Z-0539-2011)Bio-Rad Laboratories Inc2010-12-06
Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN manufactured recall (Z-0540-2011)Bio-Rad Laboratories Inc2010-12-06
in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridg recall (Z-0122-2011)Bio-Rad Laboratories Inc2010-10-22
in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Cat recall (Z-0109-2011)Bio-Rad Laboratories Inc2010-10-21
VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270- recall (Z-1901-2010)Bio-Rad Laboratories Inc2010-06-25
VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Numbe recall (Z-1902-2010)Bio-Rad Laboratories Inc2010-06-25
BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. recall (Z-1145-2010)Bio-Rad Laboratories Inc2010-03-16
Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model recall (Z-1013-2010)Bio-Rad Laboratories Inc2010-03-05
Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad La recall (Z-0867-2010)Bio-Rad Laboratories Inc2010-02-26
Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufa recall (Z-1395-2009)Bio-Rad Laboratories Inc2009-05-19
Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, recall (Z-1041-2009)Bio-Rad Laboratories Inc2009-03-24
VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250 t recall (Z-1588-2008)Bio-Rad Laboratories Inc2008-09-11
VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 t recall (Z-1589-2008)Bio-Rad Laboratories Inc2008-09-11
BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic a recall (Z-0575-2008)Bio-Rad Laboratories Inc2008-04-22
Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distr recall (Z-0733-2007)Bio-Rad Laboratories Inc2007-04-10
Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program recall (Z-0376-2007)Bio-Rad Laboratories Inc2007-01-25
Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223 recall (Z-0289-06)Bio-Rad Laboratories Inc2005-12-15
Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTIO recall (Z-0659-05)Bio Rad Laboratories, Inc.2005-03-29
Platelia Aspergillus EIA recall (Z-0348-04)Bio Rad Laboratories, Inc.2004-01-14

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