761 results
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29ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·October 17, 2012
bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704
FDA Recall
Terminated
·bioMerieux, Inc.·Product code MDB·November 5, 2007
BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
FDA Recall
Terminated
·Biomerieux, Inc.·Product code GJS·December 23, 2002
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·September 27, 2017
VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.
FDA Recall
Terminated
·bioMerieux Inc·Product code LON·January 15, 2004
VITEK 2 Gram Negative Susceptibility Card, AST-N172, REF 410 298, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N090, REF 22 240, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-GN35, REF 22 286, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-GN43, REF 410 759, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N137, REF 22 324, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N155, REF 22 352, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N093, REF 22 243, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N116, REF 22 289, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N167, REF 410 138, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N086, REF 22 234, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N106, REF 22 264, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N132, REF 22 316, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N171, REF 410 249, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N158, REF 22 355, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010
VITEK 2 Gram Negative Susceptibility Card, AST-N163, REF 410 084, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·September 16, 2010