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: 40193489744201 (Case); 10193489744200 (Ea) Lots: 19KAA457 19LAB178 20FAB341 20IAA286 20WBC414 21CBK056 21EBG180 21HBC490 21KBB192 22ABJ687 22DBO057 22GBO519 22IBB016 22LBC924 23BBN989 23EBF212 23GBA753 23IBD142 23LBJ724 24BBI191 24FBC575 24GBX259
40193489744201, 10193489744200
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.