Bio-Rad Laboratories, Inc.
Summary
- Total Recalls
- 27
- 510(k) Clearances
- 128
- Inspections
- 36
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2515-2025 | Class II | Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a | May 30, 2025 |
| Z-1358-2024 | Class II | Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit | February 15, 2024 |
| Z-1572-2023 | Class II | BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack | February 28, 2023 |
| Z-1377-2023 | Class II | BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD | February 21, 2023 |
| Z-1378-2023 | Class II | BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD | February 21, 2023 |
| Z-0342-2023 | Class II | CMV IgM EIA, in vitro diagnostic. | October 19, 2022 |
| Z-1096-2022 | Class II | BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack | April 14, 2022 |
| Z-1208-2022 | Class II | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000 | April 7, 2022 |
| Z-0806-2022 | Class II | BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack | February 8, 2022 |
| Z-0807-2022 | Class II | BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL | February 8, 2022 |
| Z-0236-2022 | Class II | BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphili | September 17, 2021 |
| Z-0235-2022 | Class II | BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphili | September 17, 2021 |
| Z-2982-2020 | Class II | BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:036105206530 | April 21, 2020 |
| Z-0082-2022 | Class II | BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Ki | November 1, 2019 |
| Z-1906-2019 | Class II | EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 9 | January 10, 2019 |
| Z-1743-2019 | Class II | MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in co | June 8, 2018 |
| Z-1742-2019 | Class II | MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use | June 8, 2018 |
| Z-2541-2018 | Class II | PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader | April 2, 2018 |
| Z-0807-2016 | Class II | EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vi | December 22, 2015 |
| Z-0695-2016 | Class II | D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for s | December 15, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K183446 | BioPlex 2200 Lyme Total | March 12, 2019 |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | February 13, 2019 |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | June 22, 2018 |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | September 13, 2017 |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | May 19, 2017 |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Sy | May 11, 2017 |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Mark | January 10, 2017 |
| K161687 | D-10 Hemoglobin A1c Program | October 14, 2016 |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek | May 10, 2016 |
| DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, L | March 28, 2016 |
| K150300 | Liquichek Cardiac Markers Plus Control LT | December 11, 2015 |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | December 9, 2015 |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | March 24, 2015 |
| K143379 | Liquichek Maternal Serum II Control | March 13, 2015 |
| K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) | January 9, 2015 |
| K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | June 25, 2014 |
| K141073 | LIQUICHEK TUMOR MARKER CONTROL | June 23, 2014 |
| K140916 | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK | May 6, 2014 |
| K140764 | LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK | April 25, 2014 |
| K134013 | LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOC | April 24, 2014 |