Z-1957-2025 Class II Ongoing
FDA device recall Z-1957-2025 was initiated by Microbiologics Inc on May 27, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 3 total.
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 total
Product 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 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.
Distribution Pattern
US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
Code Information
01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21