FDA Device recall Z-0618-2019
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 C…
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 C… by Biomerieux, citing false resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0618-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-22 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
Reason
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Identifiers
| code_info | Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 |
|---|
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-0618-2019%22
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