CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
- Recall Initiated
- February 26, 2013
- Posted
- May 4, 2014
- Terminated
- May 6, 2014
- Recall Number
- Z-1545-2014
- Quantity
- 1 unit
- Firm Location
- Norwood, MA
Reason for Recall
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Distribution
US Distribution in the state of: CA.
Lot / Code Info
Serial Number: 212809
Root 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.
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