medical Class II Updated 2023-09-06

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

Recalled Product

epoc BGEM BUN 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: 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)
View official government recall

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