Recall Z-2058-2014 ยท CIZ Radioimmunoassay, Androstenedione
Siemens Healthcare Diagnostics Inc.
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
| Date | Jul 15, 2014 (initiated Jun 9, 2014) |
| Status | Terminated |
| Reason | The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 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, Ireland, Italy, Japan, Korea, Netherlands, Paraguay, Peru, South Africa, Spain, Sweden, Switzerland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954755 | COAT-A-COUNT DIRECT ANDROSTENEDIONE Diagnostic Products Corp., Nov 29, 1995 |