Susceptibility Test Cards, Antimicrobial
Microbiology · 21 CFR 866.1640
Recent MDR events
10 adverse event reports on file
- VITEK® 2 AST-P586Jun 23, 2016MalfunctionBiomerieux, Inc1950204-2016-00061
- VITEK 2 GRAM-NEGATIVE SUSCEPTABILITY TEST KITMay 12, 2014MalfunctionBiomerieux, Inc.1950204-2014-00005
- VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KITMay 7, 2014MalfunctionBiomerieux, Inc.1950204-2014-00003
- VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY TEST KITApr 23, 2014MalfunctionBiomerieux, Inc.1950204-2014-00002
- VITEK2Feb 22, 2010MalfunctionBiomeriuexMW5014906
- VITEK SYSTEMJul 27, 2009InjuryBiomerieux, Inc.1950204-2009-00001
- VITEK 2 SYSTEMMar 24, 2008MalfunctionBiomerieux, Inc.1950204-2008-00001
- GN 09May 18, 2007OtherBiomerieuxMW5001916
- VITEK 2 SUSCEPTIBILITY CARD, AST-N045Jun 30, 2006MalfunctionBiomerieux, Inc.1950204-2006-00001
- SUSCEPTIBILITY CARDMar 4, 1994OtherVitek Systems, Inc.MW1000960
Event type breakdown
Most-reported manufacturers
Recalls
39 recall events for this product code
- Biomerieux IncOpen, ClassifiedFeb 2, 2026
VITEK 2 Gram-negative Susceptibility Cards Containing
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
Z-1236-2026 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0856-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0857-2023 · View FDA record ↗ - Biomerieux IncTerminatedMay 11, 2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Z-1639-2016 · View FDA record ↗ - Biomerieux IncTerminatedMay 11, 2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Z-1640-2016 · View FDA record ↗ - Biomerieux IncTerminatedMay 11, 2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Z-1641-2016 · View FDA record ↗ - Biomerieux IncTerminatedMay 11, 2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Z-1642-2016 · View FDA record ↗ - Biomerieux IncTerminatedMay 11, 2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Z-1643-2016 · View FDA record ↗ - Biomerieux IncTerminatedMay 11, 2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Z-1644-2016 · View FDA record ↗ - Biomerieux IncTerminatedMay 11, 2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Z-1645-2016 · View FDA record ↗
Registered firms
121 firms currently registered for this product code
510(k) clearances
16 clearances for this product code
- Microtech Medical Systems, Inc.Sep 20, 1985
K852613 · MIC-CONCEPT SYSTEM
- Austin Biological LaboratoriesSep 16, 1985
K853596 · PRECEPT CEFOPERAZONE
- Austin Biological LaboratoriesSep 16, 1985
K853273 · PRECEPT CEFTRIAXONE
- Austin Biological LaboratoriesSep 16, 1985
K853685 · PRECEPT TM CARBENICILLIN
- Austin Biological LaboratoriesSep 16, 1985
K853772 · PRECEPT METHICILLIN
- Austin Biological LaboratoriesSep 13, 1985
K853689 · PRECEPT TM MOXALACTAM
- Austin Biological LaboratoriesSep 13, 1985
K853686 · PRECEPT TM AMIKACIN
- Austin Biological LaboratoriesSep 13, 1985
K853684 · PRECEPT KANAMYCIN
PMA approvals
1 premarket approvals for this product code