Becton Dickinson & Co.: BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;

Hazard

There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.

Details from the source

Reason for recall: There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care. Distribution: US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA. Quantity: 23 units Lot/code info: Catalog (Ref): 444900; UDI-DI: 00382904449001; Serial Numbers: IA00084, IA00054, IA00055, IA00088, IA00041, IA00071, IA00085, IA00007, IA00014, IA00005, IA00053, IA00073, IA00081, IA00011, IA00012, IA00027, SL01023, IA00026, IA00050, IA00034, IA00025, IA00086, IA00108,

UPC codes

00382904449001

Source

Official record: FDA (Device enforcement) ↗

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