CLASS III Device recall · Reported 14 May 2014 · FDA Enforcement Report
Clinitek Status+ Analyzer (portable urine chemistry analyzer) recalled
Siemens Healthcare Diagnostics is recalling Clinitek Status+ Analyzer (portable urine chemistry analyzer), distributed in California. The recall was initiated on 26 Feb 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1545-2014
- FDA event ID
- 67930
- Recalling firm
- Siemens Healthcare Diagnostics, Norwood, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Feb 2013
- FDA classified
- 4 May 2014
- Reported
- 14 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Feb 2013 | Recall initiated by company | |
| 4 May 2014 | Classified by FDA | +432 days |
| 14 May 2014 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Product as listed by the FDA
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Where it was distributed
US Distribution in the state of: CA.
Questions about this recall
Why was it recalled?
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Which lots are affected?
Serial Number: 212809
Where was it sold?
US Distribution in the state of: CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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