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Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Recalled September 6, 2023 · FDA recall Z-2477-2023 · Siemens Healthcare Diagnostics
Hazard
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. · FDA Class II
Units
473 ea
Sold at
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
Description
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Product
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Manufacturer(s)
Siemens Healthcare Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →