Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
FDA Recall Z-2058-2014 · Posted 2014-07-15
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Recalling FirmSiemens Healthcare Diagnostics Inc.
Recall StatusTerminated
Product CodeCIZ
Date Initiated2014-06-09
Date Terminated2015-07-24
Product Quantity1,164 units
Reason for Recall
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
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.
Root Cause
Under Investigation by firm
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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