Siemens Healthcare Diagnostics Inc: epoc BGEM Crea 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: 473 ea Lot/code info: UDI-DI: 00809708072254 Siemens Material Number: 10736382 Lots: 03-23002-60 (expiry 19-Jun-2023) and 03-23056-50 (expiry 12-Aug-2023)

UPC codes

00809708072254

Source

Official record: FDA (Device enforcement) ↗

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