FDA Device recall Z-0544-2022
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack
- FDA Device
- Class III
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class III recall of KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack by Microbiologics, citing potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0544-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-02-24 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN |
Product
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Reason
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Identifiers
| code_info | Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Microbiologics
- KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
FDA Device · Class II · 2025-12-31 · Microbiologics - LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
FDA Device · Class II · 2025-12-10 · Microbiologics - LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
FDA Device · Class II · 2025-08-06 · Microbiologics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0544-2022%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.