FDA Device recall Z-3134-2017
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc
- FDA Device
- Class II
- terminated
- Published 2017-09-27
On 2017-09-27 the FDA classified a Class II recall of VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc by Biomerieux, citing customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3134-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-25 |
| Published | 2017-09-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | n/a |
Product
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
Reason
Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC¿ 700327(TM) strain is positive.
Identifiers
| code_info | Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018 |
|---|
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-3134-2017%22
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