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.
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
30845357032868, 30845357014666
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.