CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report
Vitros XT 3400 Chemistry System Product recalled
Ortho-Clinical Diagnostics is recalling Vitros XT 3400 Chemistry System Product, distributed nationwide in the US. The recall was initiated on 10 Oct 2023 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-0546-2024
- FDA event ID
- 93366
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Oct 2023
- FDA classified
- 13 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Medical Software
Timeline
| 10 Oct 2023 | Recall initiated by company | |
| 13 Dec 2023 | Classified by FDA | +64 days |
| 20 Dec 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Where it was distributed
US Nationwide. Global Distribution.
Questions about this recall
Is Vitros XT 3400 Chemistry System Product recalled?
Yes. Ortho-Clinical Diagnostics recalled Vitros XT 3400 Chemistry System Product on 10 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0546-2024.
Why was it recalled?
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
Which lots are affected?
Product Code: 6844458, UDI-DI: 10758750031986; Serial Numbers: J34500140 J34500113 J34500180 J34500114 J34500257 J34500116 J34500289 J34500117 J34500319 J34500123 J34500386 J34500128 J34500422 J34500129 J34500447 J34500130 J34500473 J34500139 J34500474 J34500190 J34500510 J34500261 J34500539 J34500269 J34500547 J34500271 J34500579 J34500292 J34500588 J34500301 J34500622 J34500337 J34500656 J34500356 J34500777 J34500363 J34500818 J34500515 J34500887 J34500520 J34500893 J34500536 J34500896 J34500582 J34500911 J34500609 J34500931 J34500628 J34500658 J34500711 J34500793
Where was it sold?
US Nationwide. Global Distribution.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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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