FDA-Device2014-07-23Class II
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics Inc.
Hazard
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
Sold states
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
Affected count
1,164 units
Manufactured in
5736 W 96th St, N/A, Los Angeles, CA, United States
Products
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2058-2014Don't want to check this manually?
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