Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Reason for recall: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization. Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA. Quantity: 626,305 Total Kits (US only) Lot/code info: UDI/DI: 40195327139941 (Case), 10195327139940 (Ea), Lots 22HLA350 22HLB291
40195327139941, 10195327139940
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.