FDA Device recall Z-1534-2020
VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed f…
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed f… by Biomerieux, citing the top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1534-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-05 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomerieux |
| Distribution | n/a |
Product
VITEK 2 card AST-N371 - Product Usage: The 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
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
Identifiers
| code_info | REF: 422024 Lot Number: 0210932204 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1534-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.