KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960;
FDA device recall Z-1957-2025 · posted 2025-06-11 · Open, Classified
Recall details
- Recalling firm
- Microbiologics Inc
- Reason for recall
- 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.
- Action taken
- On May 27, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were informed of the affected products containing the wrong microorganisms. Customers were instructed to review lab procedures to understand how this information affects their usage, and then to use or discard the product depending on the lab procedures and how the issue affects usage. Distributors of the affected product were instructed to contact end users who have received the affected items.
- Root cause
- Mixed-up of materials/components
- Status
- Open, Classified
- Product code
- JTR
- Quantity affected
- 3 total
- Distribution
- US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
- Date initiated
- 2025-05-27
- Date posted
- 2025-06-11
- Location
- Saint Cloud, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |