CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
Vitros XT 3400 Chemistry System recalled by Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics is recalling Vitros XT 3400 Chemistry System, distributed nationwide in the US. The recall was initiated on 26 Jan 2024 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-1232-2024
- FDA event ID
- 93927
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jan 2024
- FDA classified
- 1 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 26 Jan 2024 | Recall initiated by company | |
| 1 Mar 2024 | Classified by FDA | +35 days |
| 13 Mar 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
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 XT 3400 Chemistry System, Catalog No. 6844458
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Questions about this recall
Why was it recalled?
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
Which lots are affected?
VITROS System Software Versions 3.8.0 or 3.8.1 UDI-DI 10758750031986 Serial Numbers: US: J34500140 J34500180 J34500257 J34500289 J34500319 J34500386 J34500422 J34500447 J34500473 J34500474 J34500510 J34500539 J34500547 J34500579 J34500588 J34500622 J34500656 J34500777 J34500818 J34500861 J34500887 J34500893 J34500896 J34500911 J34500931 OUS: J34500123 J34500128 J34500129 J34500130 J34500190 J34500261 J34500269 J34500271 J34500292 J34500301 J34500337 J34500356 J34500363 J34500515 J34500520 J34500536 J34500582 J34500609 J34500628 J34500658 J34500711 J34500793 J34500802 J34500940 J34500960 J34500962
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
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
4 other products · FDA event 93927This product is part of a recall event; the main page for the event is Vitros XT 7600 Integrated System recalled by Ortho-Clinical Diagnostics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vitros XT 7600 Integrated System recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Vitros 4600 Chemistry System recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Vitros 3600 Immunodiagnostic System recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
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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|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |