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Bio-Rad Laboratories

17 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit recall (Z-1358-2024)Bio-Rad Laboratories2024-03-22
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade softwar recall (Z-0032-2014)Bio-Rad Laboratories2013-10-21
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog nu recall (Z-2398-2012)Bio-Rad Laboratories2012-09-17
"BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" recall (Z-3051-2011)Bio-Rad Laboratories2011-08-22
Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version recall (Z-2201-2011)Bio-Rad Laboratories2011-05-19
BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part: "BIO-R recall (Z-2082-2011)Bio-Rad Laboratories2011-04-27
Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220 recall (Z-1620-2010)Bio-Rad Laboratories2010-05-20
Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High recall (Z-0908-2010)Bio-Rad Laboratories2010-03-02
Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Ce recall (Z-2428-2008)Bio-Rad Laboratories2008-09-19
Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product lab recall (Z-2429-2008)Bio-Rad Laboratories2008-09-19
Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney Substrat recall (Z-2430-2008)Bio-Rad Laboratories2008-09-19
Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic. recall (Z-1189-2008)Bio-Rad Laboratories2008-08-20
BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad recall (Z-1156-2008)Bio-Rad Laboratories2008-06-11
BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - ma recall (Z-1157-2008)Bio-Rad Laboratories2008-06-11
BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - ma recall (Z-1158-2008)Bio-Rad Laboratories2008-06-11
BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) th recall (Z-1159-2008)Bio-Rad Laboratories2008-06-11
Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catal recall (Z-0065-2008)Bio-Rad Laboratories2007-10-31

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Every clearance here is in the API, with alerts when new ones post.