FDAFDA · Food and drugs·Recall number Z-2058-2014
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Published July 23, 2014 · Recall initiated: June 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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