Recall archive / FDA device enforcement
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 — FDA record Z-0546-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 51 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0546-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide. Global Distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 20, 2023
- Recall initiation date
- Oct 10, 2023
- Center classification date
- Dec 13, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.