FDA Enforcement
Class II
Ongoing
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Recall: Z-1957-2025
·
Reported June 18, 2025
Enforcement
- Recall Number
- Z-1957-2025
- Event ID
- 96974
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Microbiologics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 18, 2025
- Initiation Date
- May 27, 2025
- Classification Date
- June 11, 2025
- Address
- 200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States
Description
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.
Code Info
01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21
Distribution
US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
Quantity
3 total