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Recall Observatory FDA recall evidence

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

Z-1957-2025

May 27, 2025

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 96974
Status
Ongoing
Classification
Class II
Quantity
3 total
Official record key
device-enforcement:Z-1957-2025

Official wording

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 information: 01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.