Device product
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Z-2058-2014
Product summary
- Event
- Event 68595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,164 units
- Official record key
device-enforcement:Z-2058-2014
Official wording
Reason: The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
Code information: Lot No. TKAN1 batch 587 TKAN1 batch 588 TKAN1 batch 589 TKAN1 batch 590 TKAN1 batch 591 TKAN1 batch 592 TKAN1 batch 593 TKAN1 batch 594 TKAN1 batch 595 TKAN1 batch 596 TKAN1 batch 597 TKAN1 batch 598 TKAN1 batch 599 TKAN1 batch 600
Distribution pattern: 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, and Uruguay
Derived failure modes
-
Unknown
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.