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: 40195327109784 (Case); 10195327109783 (Ea) Lots: 22FBK384 22GBO520
40195327109784, 10195327109783
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.