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
Published June 12, 2024 · Recall initiated: May 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Distributor
- Worldwide - US Nationwide and the country of Columbia.
- Lot
- UDI-DI: 10758750000937 Lot Number: 1200 Exp. Date: 30-Sep-2024
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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