FDA-Device2023-09-06Class II
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Siemens Healthcare Diagnostics Inc
Hazard
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Sold states
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
Affected count
348 ea
Manufactured in
2 Edgewater Dr, N/A, Norwood, MA, United States
Products
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2478-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief