FDA Device recall Z-1742-2020
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to…
- FDA Device
- Class II
- ongoing
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to… by Biomerieux, citing there is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1742-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-03-11 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomerieux |
| Distribution | n/a |
Product
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
Reason
There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
Identifiers
| code_info | VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1742-2020%22
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