Device product
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Z-2477-2023
Product summary
- Event
- Event 92537
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 473 ea
- Official record key
device-enforcement:Z-2477-2023
Official wording
Reason: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Code information: UDI-DI: 00809708072254 Siemens Material Number: 10736382 Lots: 03-23002-60 (expiry 19-Jun-2023) and 03-23056-50 (expiry 12-Aug-2023)
Distribution pattern: 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
Derived failure modes
-
Unknown
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.