Recall archive / FDA device enforcement
VITROS XT 3400 Chemistry System, Catalog No. 6844458 — FDA record Z-1232-2024
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 Jan 26, 2024. 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, Catalog No. 6844458
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 25 US; 26 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1232-2024
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 | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
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
- Mar 13, 2024
- Recall initiation date
- Jan 26, 2024
- Center classification date
- Mar 1, 2024
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.