Coat-A-Count Direct Androstenedione — Class II medical device recall Z-2058-2014
Terminated recall by Siemens Healthcare Diagnostics Inc., reported 2014-07-23, distributed nationwide. The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms
| Recall number | Z-2058-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc., Los Angeles, CA, United States |
| Recall initiated | 2014-06-09 |
| Classified | 2014-07-15 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2015-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BO, CA, CH, CL, CO, DE, ES, FI, GB, GR, IE, IN, IT, JP, KR, NL, PE, PY, SE, UY, ZA |
| Quantity | 1,164 units |
| Reason classes | potency |
| Lot numbers | 587, 588, 589, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 600, TKAN1 |
| Model numbers | TKAN1 |
Product
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Reason for recall
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2058-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.