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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