Device product
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 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.
Z-3180-2018
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 80860
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10919 cartons
- Official record key
device-enforcement:Z-3180-2018
Official wording
Reason: Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).
Code information: Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403
Distribution pattern: Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,
Derived failure modes
-
Unknown
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).