CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report
Vitros 250 Chemistry System, clinical chemistry analyzer recalled
Ortho Clinical Diagnostics is recalling Vitros 250 Chemistry System, clinical chemistry analyzer, distributed nationwide in the US. The recall was initiated on 8 Jul 2019 and the FDA has classified it as Class II.
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-2174-2019
- FDA event ID
- 83322
- Recalling firm
- Ortho Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jul 2019
- FDA classified
- 6 Aug 2019
- Reported
- 14 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Jul 2019 | Recall initiated by company | |
| 6 Aug 2019 | Classified by FDA | +29 days |
| 14 Aug 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VITROS 250 Chemistry System, clinical chemistry analyzer
Where it was distributed
Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Questions about this recall
Why was it recalled?
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Which lots are affected?
product code: 8132086 UDI: 10758750004409 Affected software : Version 9.7
Where was it sold?
Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
11 other products · FDA event 83322This product is part of a recall event; the main page for the event is Vitros 5600 Integrated System, clinical chemistry analyzer recalled.
More recalls from Ortho Clinical Diagnostics
All 311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products LAC Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products Ca Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides (Japan) recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
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