CLASS II Device recall · Reported 23 Jul 2014 · FDA Enforcement Report
Coat-A-Count Direct Androstenedione, SMN recalled
Siemens Healthcare Diagnostics is recalling Coat-A-Count Direct Androstenedione, SMN 10381049, distributed nationwide in the US. The recall was initiated on 9 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2058-2014
- FDA event ID
- 68595
- Recalling firm
- Siemens Healthcare Diagnostics, Los Angeles, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jun 2014
- FDA classified
- 15 Jul 2014
- Reported
- 23 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Jun 2014 | Recall initiated by company | |
| 15 Jul 2014 | Classified by FDA | +36 days |
| 23 Jul 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Where it was distributed
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
Nationwide CaliforniaMichiganNorth CarolinaNebraskaNew YorkOhioPennsylvaniaTexasVirginia
Questions about this recall
Why was it recalled?
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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