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Recall

Class II — Biomerica

Recalling firmBiomerica, Inc.
Registered facilityBiomerica (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonA potential issue with false high values.
ProductCalcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
Quantity1,062 units
DistributionWorldwide 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.
Initiated2014-09-18
Classified2014-11-26
Terminated2015-03-28
Recall numberZ-0467-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Biomerica (Z-0467-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69621/

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