FDA Device recall Z-0588-2022
QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set
- FDA Device
- Class II
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set by Microbiologics, citing tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0588-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-18 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Reason
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
Identifiers
| code_info | Catalog Number: 5220P; Lot Numbers (Expiration Date): 5220-01 (04/30/2020), 5220-02 (07/31/2020), 5220-03 (10/31/2020),…Catalog Number: 5220P; Lot Numbers (Expiration Date): 5220-01 (04/30/2020), 5220-02 (07/31/2020), 5220-03 (10/31/2020), 5220-04 (10/31/2020), 5220-05 (10/31/2020), 5220-06 (01/31/2021); UDI: 70845357026551 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0588-2022%22
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