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FDA (Device enforcement)Recalled 2025-05-27class ii

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

Hazard

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.

Details from the source

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. Quantity: 3 total Lot/code info: 01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21

UPC codes

30845357032868, 30845357014666

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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