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Biomerieux Inc

514 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
VeriCal Calibrator Set recall (Z-0032-06)BIOMERIEUX, INC.2005-10-22
Bac T/ALERT 3D Control Module recall (Z-0612-05)BIOMERIEUX, INC.2005-09-07
Bac T/ALERT 3D Combination Module recall (Z-0613-05)BIOMERIEUX, INC.2005-09-07
Bac T/ALERT 3D 60 recall (Z-0614-05)BIOMERIEUX, INC.2005-09-07
Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704 recall (Z-0843-05)BIOMERIEUX, INC.2005-05-18
VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x recall (Z-0316-04)Biomerieux, Inc.2004-07-20
VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic us recall (Z-0721-04)bioMerieux Inc2004-07-20
VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic u recall (Z-0725-04)bioMerieux Inc2004-07-20
NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of recall (Z-0735-04)Biomerieux, Inc.2004-07-20
Coag-A-Mate MTX and MTX II Instrument Operator Manual recall (Z-0771-04)Biomerieux, Inc.2004-07-20
VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic us recall (Z-0917-04)bioMerieux Inc2004-07-20
VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic u recall (Z-0919-04)bioMerieux Inc2004-07-20
BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Du recall (Z-0628-03)Biomerieux, Inc.2003-03-06
Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. recall (Z-0629-03)Biomerieux, Inc.2003-03-06
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