Device product
Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
Z-0467-2015
Product summary
- Firm
- Biomerica
- Event
- Event 69621
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,062 units
- Official record key
device-enforcement:Z-0467-2015
Official wording
Reason: A potential issue with false high values.
Code information: Lot No. 2041, 2071, 2089, 2124, 2167, 2178, 2180.
Distribution pattern: Worldwide Distribution -- USA, including the states of NH, CA, NJ, FL; and, the countries of Russia, Ukraine, Switzerland, Spain, Italy, Serbia, China, France, Pakistan, Austria, United Kingdom, Egypt, and India.
Derived failure modes
-
Unknown
A potential issue with false high values.