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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Immunodiagnostic Products Vitamin B12 Range Verifier

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 Class 3 Device Recall VITROS Immunodiagnostic Products Vitamin B12 Range Verifiersee related information
Date Initiated by FirmMay 08, 2024
Date PostedJune 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2019-2024
Recall Event ID 94650
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
ProductVITROS 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
Code Information UDI-DI: 10758750000937 Lot Number: 1200 Exp. Date: 30-Sep-2024
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactMr. Joe Falvo
585-453-3000
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionQuidelOrtho 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 Commerce76 units
DistributionWorldwide - US Nationwide and the country of Columbia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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