Z-2058-2014Class II

Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics

Name: Z-2058-2014 Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Creator: Siemens Healthcare Diagnostics Inc.
Published: 2014-06-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-06-09 / Terminated

FDA source

Siemens Healthcare Diagnostics Inc. began a recall of Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics on 2014-06-09. FDA classified it as Class II and gives the reason as "The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2058-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-09
Posted: 2014-07-15
Terminated: 2015-07-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Product code: CIZ Radioimmunoassay, Androstenedione
Reason for recall: The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 1,164 units
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2058-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2058-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-15

Product code CIZ

K954755Class ICoat-a-Count Direct AndrostenedioneDiagnostic Products Corp. / cleared 1995-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)