VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 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.
This recall has been terminated (originally issued August 13, 2018).
- Company
- Biomerieux, Inc.
- Recall Initiated
- August 13, 2018
- Terminated
- November 2, 2020
- Recall Number
- Z-3179-2018
- Quantity
- 2538 cartons
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
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).
Distribution
Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,
Lot / Code Info
Lot Numbers: 7400410103, 7400697403
Root Cause
Process control
Action Taken
The firm initiated the recall by email on 08/13/2018. The firm requested the consignee discard the impacted product and contact the local bioMerieux representative for credit.