Data Foundry

Medical device recalls 2014

Calcitonin ELISA Kit — Class II medical device recall Z-0467-2015

Terminated recall by Biomerica, reported 2014-12-03, distributed in CA, FL, NH, NJ. A potential issue with false high values.

Recall numberZ-0467-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBiomerica, Irvine, CA, United States
Recall initiated2014-09-18
Classified2014-11-26
Reported by FDA2014-12-03
Terminated2015-03-28
DistributedCA, FL, NH, NJ
Countries outside the USAT, CH, CN, EG, ES, FR, GB, IN, IT, PK, RS, RU, UA
Quantity1,062 units
Lot numbers2041, 2071, 2089, 2124, 2167, 2178, 2180

Product

Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.

Reason for recall

A potential issue with false high values.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0467-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.