medical Class II Updated 2023-09-06

Siemens Healthcare Diagnostics Inc recalls epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host S

Recalled Product

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 / 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: 00630414243788 Siemens Material Number: 10736516 Lots: 04-23043-51 (expiry 30-Jul-2023)
View official government recall

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