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VITROS recallZ-2245-2024 · Ortho-Clinical Diagnostics, Inc. · initiated May 14, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling design

What the company is doing

QuidelOrtho issued a hardcopy customer letters to Distributors and End-USers (Ref. CL2024-130) via FedEx overnight courier and/ or electronically using ORTHO PLUS e-Communications on 22 May 2024. Letter states reason for recall, health risk and action to take: Discontinue using, render unusable, and discard any remaining inventory of VITROS Chemistry Products Calibrator Kit 29, Lot 2953 by the correct expiration date, 24-Jul-2024. " If you have previously obtained a Certificate of Analysis, then download a new one from ORTHO PLUS on quidelortho.com. " To help assure the product is not supported beyond its expiry date, upload ADD DRV 6286 or higher before 24-Jul-2024. Once DRV 6286 or higher has been uploaded the product will no longer be supported and you must use an alternate lot. " Complete the enclosed Confirmation of Receipt form no later than May 29, 2024. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will provide credit or replacement of your existing inventory of VITROS Chemistry Products Calibrator Kit 29, Lot 2953. " Save this notification with your User Documentation or post this notification by each VITROS 5,1 FS/4600/5600/XT 7600 System until the issue has been resolved. " Please forward this notification if the product was distributed outside of your facility. Contact Information. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.

Recall details

Recall number
Z-2245-2024
Status
Open, Classified
Initiated by the company
May 14, 2024
Posted by the FDA
Jul 1, 2024
Recalling firm
Ortho-Clinical Diagnostics, Inc.
Quantity
1718
Product code
JMO
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.

Product description

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

Code information (models, lots, serial numbers)

(UDI/GTIN# 10758750002672; Lot Number 2953; Expiration Date: 24-Jul-2024

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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