FDA Device recall Z-0467-2015
Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II recall of Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum by Biomerica, citing A potential issue with false high values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0467-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-18 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerica |
| Distribution | CA, FL, NH, NJ |
Product
Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
Reason
A potential issue with false high values.
Identifiers
| code_info | Lot No. 2041, 2071, 2089, 2124, 2167, 2178, 2180. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0467-2015%22
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