epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Recall Initiated
- June 1, 2023
- Posted
- August 28, 2023
- Recall Number
- Z-2476-2023
- Quantity
- 3201 ea
- Firm Location
- Norwood, MA
Reason for Recall
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Distribution
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
Lot / Code Info
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)
Root Cause
Under Investigation by firm
Action Taken
Consignees were notified via an Urgent Medical Device Correction letter beginning June 5, 2023. Consignees were informed of the issue and were provided a workaround and actions to take. The next sensor configuration/software version, sensor configuration 42.1/epoc Host SW v3.38.2 /epoc NXS SW v4.11.11, is available to customers in Siemens Healthineers Document Library or the epoc Live Update Service (eLUS). This next sensor configuration, 42.1, mitigates the issue.