CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
FDA device recall Z-1545-2014 · posted 2014-05-04 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Reason for recall
- Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
- Action taken
- On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- KQO
- Quantity affected
- 1 unit
- Distribution
- US Distribution in the state of: CA.
- Date initiated
- 2013-02-26
- Date posted
- 2014-05-04
- Date terminated
- 2014-05-06
- Location
- Norwood, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 (K091216) | Siemens Healthcare Diagnostics | 2009-10-09 |