Siemens Healthcare Diagnostics Inc Recall 92537
Description: epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Siemens Healthcare Diagnostics Inc Recall 92537 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2477-2023 |
| Event ID | 92537 |
| Event Description | epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 |
| Product Type | Devices |
| 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 |
| Quantity | 473 ea |
| Recall Reason | There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. |
| Device Classification | 20230906 |
| Device Code Info | UDI-DI: 00809708072254 Siemens Material Number: 10736382 Lots: 03-23002-60 (expiry 19-Jun-2023) and 03-23056-50 (expiry 12-Aug-2023) |
| Center Classification Date | 20230828 |
| Recall Initiation Date | 20230601 |
| Recalling Firm | Siemens Healthcare Diagnostics Inc |
| Initial Notification | Letter |
| Similar To |