medical Class II Updated 2023-09-06

Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS

Recalled Product

epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1


Hazard / Issue

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

Issued by

FDA

Affected States: 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, TX
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)
View official government recall

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