Siemens Coat-A-Count Direct Androstenedione Assay Recalled for Inaccurate Results
Siemens Healthcare Diagnostics is recalling Coat-A-Count Direct Androstenedione assays because they show higher frequency of results greater than 10 ng/mL compared to other platforms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving medical devices where inaccurate results could impact patient care, even if specific injuries are not yet reported in the text.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling 1,164 units of Coat-A-Count Direct Androstenedione assays (SMN 10381049, Catalog Number TKAN1). The recall covers specific batches of the product, including TKAN1 batches 587 through 600.
The agency classified this as a Class II recall. The recall was initiated because the assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms. This discrepancy may affect the accuracy of diagnostic results for androstenedione levels.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries such as Canada, Germany, Japan, and the United Kingdom. Users of these assays should stop using the affected batches and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- Product
- Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Hazard
- Affected units
- 1,164
Distribution
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