Z-0467-2015Class II

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

Name: Z-0467-2015 Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination...
Creator: Biomerica
Published: 2014-09-18
License: https://open.fda.gov/license/

Biomerica / initiated 2014-09-18 / Terminated / root cause: manufacturing process

FDA source

Biomerica began a recall of Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum on 2014-09-18. FDA classified it as Class II and gives the reason as "A potential issue with false high values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0467-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-18
Posted: 2014-12-16
Terminated: 2015-03-28
Recalling firm: Biomerica
Product: Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
Product code: JKR Radioimmunoassay, Calcitonin
Reason for recall: A potential issue with false high values.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
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.
Quantity in commerce: 1,062 units
Distribution: 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.
Product codes and lots: Lot No. 2041, 2071, 2089, 2124, 2167, 2178, 2180.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0467-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0467-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26

Product code JKR

K982491Class IISangui Biotech, Inc. Calcitonin Elisa KitSangui Biotech, Inc. / cleared 1998-09-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)