Recall archive / FDA device enforcement
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) — FDA record Z-1230-2024
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 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
- 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
- 15 US; 43 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1230-2024
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 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers: US: J46000208 J46000209 J46000240 J46000497 J46000864 J46000865 J46000898 J46001030 J46001064 J46001125 J46001132 J46001293 J46001462 J46001703 J46001704 OUS: J46000150 J46000933 J46000162 J46001029 J46000190 J46001041 J46000247 J46001042 J46000296 J46001087 J46000393 J46001119 J46000410 J46001186 J46000478 J46001187 J46000499 J46001210 J46000531 J46001217 J46000564 J46001289 J46000617 J46001541 J46000772 J46001565 J46000788 J46001571 J46000800 J46001609 J46000801 J46001629 J46000812 J46001639 J46000821 J46001645 J46000855 J46001680 J46000859 J46000948 J46000861 J46000983 J46000910 |
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.