FDA Device recall Z-3179-2018
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp by Biomerieux, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3179-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-13 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
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.
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).
Identifiers
| code_info | Lot Numbers: 7400410103, 7400697403 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3179-2018%22
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