FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc.: Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
- Recall number
- Z-2058-2014
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Product
- Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
- Status
- Terminated
- Initiated
- 2014-06-09
- Posted
- 2014-07-15
- Terminated
- 2015-07-24
- Reason
- The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
- 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
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K954755"]
- PMA numbers
- not on file
- Product code
- CIZ
- Firm FEI
- 3005250747
- Firm city
- Los Angeles
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28