Siemens Healthcare Diagnostics Inc: epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

Hazard

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

Details from the source

Reason for recall: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. Distribution: US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam Quantity: 3201 ea Lot/code info: UDI-DI: 00809708121860 Siemens Material Number: 10736515 Lots: 04-23003-60 (expiry 20-Jun-2023), 11-22337-60 (expiry 20-May-2023), 04-23034-40 (expiry 21-Jul-2023), 04-23059-50 (expiry 15-Aug-2023), 04-23059-60 (expiry 15-Aug-2023), and 04-23069-40 (expiry 25-Aug-2023)

UPC codes

00809708121860

Source

Official record: FDA (Device enforcement) ↗

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