CLINITEK Status+ Analyzer — Class III medical device recall Z-1545-2014
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2014-05-14, distributed in CA. Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
| Recall number | Z-1545-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2013-02-26 |
| Classified | 2014-05-04 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2014-05-06 |
| Distributed | CA |
| Quantity | 1 units |
| Reason classes | unapproved product |
| Serial numbers | 212809 |
| Model numbers | 10490946 |
Product
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Reason for recall
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
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-1545-2014. 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.