Class II — Siemens Healthcare Diagnostics Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms. |
| Product | Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics |
| 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 |
| Initiated | 2014-06-09 |
| Classified | 2014-07-15 |
| Terminated | 2015-07-24 |
| Recall number | Z-2058-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics Inc. (Z-2058-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68595/
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