Z-2245-2024 Class III Ongoing
FDA device recall Z-2245-2024 was initiated by Ortho-Clinical Diagnostics, Inc. on May 14, 2024 and is designated Class III. 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… The recall status is ongoing. Affected quantity: 1718.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 10, 2024
- Initiation Date
- May 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1718
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.
Distribution Pattern
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2245-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026