Z-2477-2023 Class II Ongoing
FDA device recall Z-2477-2023 was initiated by Siemens Healthcare Diagnostics Inc on June 1, 2023 and is designated Class II. Reason for recall: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. The recall status is ongoing. Affected quantity: 473 ea.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- June 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 473 ea
Product Description
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
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 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
Code Information
UDI-DI: 00809708072254 Siemens Material Number: 10736382 Lots: 03-23002-60 (expiry 19-Jun-2023) and 03-23056-50 (expiry 12-Aug-2023)