Recall archive / FDA device enforcement
VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the ca... — FDA record Z-2019-2024
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 8, 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 Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of vitamin B12 - Product Code: 6800872
- Reason
- The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.
- Classification
- Class III
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 76 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2019-2024
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-DI: 10758750000937 Lot Number: 1200 Exp. Date: 30-Sep-2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide and the country of Columbia.
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
- Jun 12, 2024
- Recall initiation date
- May 8, 2024
- Center classification date
- Jun 4, 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.