VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Ch...
FDA Recall #Z-2245-2024 — Class III — May 14, 2024
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
Reason for Recall
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.
Recalling Firm
Ortho-Clinical Diagnostics, Inc. — Rochester, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
1718
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.
Code Information
(UDI/GTIN# 10758750002672; Lot Number 2953; Expiration Date: 24-Jul-2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated