CLINITEK Status+ Analyzer (portable urine chemistry… recallZ-1545-2014 · Siemens Healthcare Diagnostics Inc · initiated Feb 26, 2013
Class III Terminated All recalls posted in May 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
FDA root cause category: Reprocessing Controls
What the company is doing
On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument.
Recall details
- Recall number
- Z-1545-2014
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Feb 26, 2013
- Posted by the FDA
- May 4, 2014
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 1 unit
- Product code
- KQO
- FDA submissions
- K091216
- Distribution
- US Distribution in the state of: CA.
Product description
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Code information (models, lots, serial numbers)
Serial Number: 212809
Other devices under the same FDA submission
2 devices cleared under K091216 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CLINITEK Status®+ Analyzer 10379675Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE89 reports
- CLINITEK Status®+ Analyzer 10379677Siemens Healthcare Diagnostics Inc. · DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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