Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Why it was 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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide. Global Distribution.
Recall record
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product type
- Devices
- Recall number
- Z-0546-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Rochester, NY
- Recall initiated
- 2023-10-10
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0546-2024 · Source: openFDA enforcement.