epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
FDA device recall Z-2478-2023 · posted 2023-08-28 · Open, Classified
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Reason for recall
- There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- CHL
- Quantity affected
- 348 ea
- 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, Norwa
- Date initiated
- 2023-06-01
- Date posted
- 2023-08-28
- Location
- Norwood, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| epoc Blood Analysis System (K200107) | Epocal, Inc. | 2020-06-05 |