FDA Device recall Z-2576-2023
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P
- FDA Device
- Class III
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class III recall of KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P by Microbiologics, citing one lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2576-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-08-14 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Reason
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
Identifiers
| code_info | UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2576-2023%22
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