FDA Device recall Z-1545-2014
CLINITEK Status+ Analyzer (portable urine chemistry analyzer)
- FDA Device
- Class III
- terminated
- Published 2014-05-14
On 2014-05-14 the FDA classified a Class III recall of CLINITEK Status+ Analyzer (portable urine chemistry analyzer) by Siemens Healthcare Diagnostics, citing device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1545-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-26 |
| Published | 2014-05-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | CA |
Product
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Reason
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Identifiers
| code_info | Serial Number: 212809 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1545-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.