Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
FDA Recall Z-0467-2015 · Posted 2014-12-16
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Recalling FirmBiomerica
Recall StatusTerminated
Product CodeJKR
Date Initiated2014-09-18
Date Terminated2015-03-28
Product Quantity1,062 units
Reason for Recall
A potential issue with false high values.
Firm Action
An Urgent Field Safety Notice dated 9/18/14 was sent to all their customers who purchased the Calcitonin ELISA Kit. The letter informed the customers of the problems identified and the actions to be taken. Customers were to examine their inventory immediately and quarantine any affected product. Also, customers were asked to notify any customers that the product was further distributed to. Customers with questions were instructed to contact their local Customer Service or Sales Representative regarding the recall notification. Customers were instructed to complete and return the enclosed response form by either fax or email as soon as possible and not later than 10/1/14.
Root Cause
Material/Component Contamination
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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