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Recall Observatory FDA recall evidence

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

June 01, 2023

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
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

    reason.no_named_rule · v1.0.0

    There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.