Recall Z-1545-2014
Siemens Healthcare Diagnostics Inc · initiated February 26, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Codes / lots: Serial Number: 212809
Reason for recall
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
FDA-determined cause: Reprocessing Controls
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.
Details
- Recall number
- Z-1545-2014
- Initiated
- February 26, 2013
- Posted by FDA
- May 4, 2014
- Terminated
- May 6, 2014
- Product code
- KQO – Automated Urinalysis System
- Quantity
- 1 unit
- Distribution
- US Distribution in the state of: CA.
- Recalling firm
- Siemens Healthcare Diagnostics Inc, Norwood, MA