Device product
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Z-2476-2023
Product summary
- Event
- Event 92537
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3201 ea
- Official record key
device-enforcement:Z-2476-2023
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: 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)
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.