KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethrali...
FDA Recall #Z-1957-2025 — Class II — May 27, 2025
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.
Recalling Firm
Microbiologics Inc — Saint Cloud, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 total
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.