FDA Device recall Z-1957-2025
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960 by Microbiologics, citing affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was pack….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1957-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-27 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Reason
Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
Identifiers
| code_info | 01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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-1957-2025%22
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