Microbiologics Inc: KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

Hazard

Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.

Details from the source

Reason for recall: Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient. Distribution: US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh. Quantity: 21 total Lot/code info: Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544

UPC codes

30845357019531, 10845357019544

Source

Official record: FDA (Device enforcement) ↗

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