Recall archive / FDA device enforcement
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and ... — FDA record Z-2245-2024
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 May 14, 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 Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Model/Catalog Number: 6802344
- Reason
- Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.
- Classification
- Class III
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 1718
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2245-2024
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 | (UDI/GTIN# 10758750002672; Lot Number 2953; Expiration Date: 24-Jul-2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Belgium, Bermuda, 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
- Jul 10, 2024
- Recall initiation date
- May 14, 2024
- Center classification date
- Jul 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.