[pending] KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis d
Pending LLM rewrite. Source: FDA_DEVICE Z-1957-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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
- Manufacturer
- Microbiologics Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 01065K: UDI-DI 30845357032868
- lot 1065-25-51
- 0621K: UDI-DI 30845357014666
- lot 621-73-21
Distribution
Distributed nationwide across the United States.
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