Ortho-Clinical Diagnostics, Inc. 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
(UDI/GTIN# 10758750002672, Lot Number 2953, Expiration Date: 24-Jul-2024
Products Sold
(UDI/GTIN# 10758750002672; Lot Number 2953; Expiration Date: 24-Jul-2024
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemi due to 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 tru. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026