Siemens Healthcare Diagnostics Inc: epoc BGEM Test Card (BUN & TCO2),Veterinary 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: 348 ea Lot/code info: UDI-DI: 00630414243788 Siemens Material Number: 10736516 Lots: 04-23043-51 (expiry 30-Jul-2023)

UPC codes

00630414243788

Source

Official record: FDA (Device enforcement) ↗

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