FDA Device recall Z-0584-2022
QC Sets and Panels: KWIK-STIK" 2 Pack
- 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" 2 Pack by Microbiologics, citing potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0584-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-01 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.
Reason
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
Identifiers
| code_info | Catalog Number: 5193P; Lot Number: 5193-10 (Expiration Date 09/30/2021), 5193-11 (Expiration Date 04/30/2021); UDI: 70845357030718 |
|---|
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-0584-2022%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.