Reported Jul 23, 2014 · Terminated
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Inc. · 5736 W 96th St · Los Angeles, CA · 90045-5544
Is this the product you have?
- Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
- Lot codes and dates
- Lot No. TKAN1 batch 587 TKAN1 batch 588 TKAN1 batch 589 TKAN1 batch 590 TKAN1 batch 591 TKAN1 batch 592 TKAN1 batch 593 TKAN1 batch 594 TKAN1 batch 595 TKAN1 batch 596 TKAN1 batch 597 TKAN1 batch 598 TKAN1 batch 599 TKAN1 batch 600
- Amount recalled
- 1,164 units
Where it was sold
Why it was recalled
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
This product could cause temporary or reversible health problems — stop using it.
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