Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitoni
FDA device recall Z-0467-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Biomerica
- Reason for recall
- A potential issue with false high values.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- JKR
- Quantity affected
- 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
- Date initiated
- 2014-09-18
- Date posted
- 2014-12-16
- Date terminated
- 2015-03-28
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SANGUI BIOTECH, INC. CALCITONIN ELISA KIT (K982491) | Sangui Biotech, Inc. | 1998-09-03 |