Recall Z-0467-2015 ยท JKR Radioimmunoassay, Calcitonin
Biomerica
Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
| Date | Dec 16, 2014 (initiated Sep 18, 2014) |
| Status | Terminated |
| Reason | A potential issue with false high values. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT Sangui Biotech, Inc., Sep 3, 1998 |