CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
This recall has been terminated (originally issued May 4, 2014).
- 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
- Official Source
- View on FDA website ↗
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.
More recalls by Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 1...
Apr 29, 2025