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Siemens Healthcare Diagnostics Inc. recalls Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Recalled July 23, 2014 · FDA recall Z-2058-2014 · Siemens Healthcare Diagnostics
Hazard
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms. · FDA Class II
Units
1,164 units
Sold at
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
Description
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
Product
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Manufacturer(s)
Siemens Healthcare Diagnostics Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →