Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Coat-A-Count Direct Androstenedione Recalled by Siemens Healthcare Diagnostics Inc. Due to The assay is demonstrating a higher frequency of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics Inc. directly.
Affected Products
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Quantity: 1,164 units
Why Was This Recalled?
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report