FDA recall Z-1957-2025

Microbiologics Inc · Class II · device

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

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

US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.

Key facts

Status
Ongoing
Initiation date
2025-05-27
Report date
2025-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1957-2025