Z-2478-2023 Class II Ongoing
FDA device recall Z-2478-2023 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: 348 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
- 348 ea
Product Description
epoc BGEM Test Card (BUN & TCO2),Veterinary 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: 00630414243788 Siemens Material Number: 10736516 Lots: 04-23043-51 (expiry 30-Jul-2023)