Z-2019-2024Class III

VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in...

Name: Z-2019-2024 VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2024-05-08
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-05-08 / Open, Classified / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS... on 2024-05-08. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2019-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-05-08
Posted: 2024-06-04
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: QuidelOrtho issued IMPORTANT PRODUCT CORRECTION NOTIFICATION (Ref. CL2024-123) to Distributors and End-Users via FedEx overnight courier and/ or electronically. Letter states reason for recall, health risk and action to take: " Discontinue using, render unusable, and discard your remaining inventory of VITROS Vitamin B12 Range Verified, Lot 1200. QuidelOrtho will replace or credit your account. Indicate quantities to be replaced or credited via the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than May 14, 2024. " Please forward this notification if the affected product was distributed outside of your facility. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
Quantity in commerce: 76 units
Distribution: Worldwide - US Nationwide and the country of Columbia.
Product codes and lots: UDI-DI: 10758750000937 Lot Number: 1200 Exp. Date: 30-Sep-2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2019-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2019-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-04

Product code JJX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)