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Recall Observatory FDA recall evidence

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

September 18, 2014

Class II

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

    reason.no_named_rule · v1.0.0

    A potential issue with false high values.