Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
FDA device recall Z-2058-2014 · posted 2014-07-15 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Reason for recall
- The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
- Action taken
- A recall letter dated 6/9/14 was sent to all customers who purchased the Coat-A-Count Direct Androstenedione because the assay is demonstrating a higher frequency of results compared to alternate platforms. The letter informs the customers of the problems identified, risks to health, and actions to be taken. Customers are instructed to complete and return the Field Correction Effectiveness Check attached to the recall letter within 30 days.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- CIZ
- Quantity affected
- 1,164 units
- Distribution
- Worldwide Distribution. US nationwide including CA, MI, NC, NE, NY, OH, PA, TX, and VA; Argentina, Austria, Belgium, Bolivia, Canada, Chile, Colombia, Finland, Germany, Great Britain, Greece, India, I
- Date initiated
- 2014-06-09
- Date posted
- 2014-07-15
- Date terminated
- 2015-07-24
- Location
- Los Angeles, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COAT-A-COUNT DIRECT ANDROSTENEDIONE (K954755) | Diagnostic Products Corp. | 1995-11-29 |