Recall Z-1545-2014 ยท KQO Automated Urinalysis System
Siemens Healthcare Diagnostics Inc
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
| Date | May 4, 2014 (initiated Feb 26, 2013) |
| Status | Terminated |
| Reason | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. |
| Root cause | Reprocessing Controls |
| Action | On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument. |
| Quantity | 1 unit |
| Distribution | US Distribution in the state of: CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091216 | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 Siemens Healthcare Diagnostics, Oct 9, 2009 |