Medical device recalls Moderate risk

Microbiologics Inc recalls KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960…

Recall date
May 27, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1957-2025
FDA classification
Class II
Brand / firm
Microbiologics Inc
Sold / distributed
US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493

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