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Recall Observatory FDA recall evidence

Device 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

Z-2245-2024

May 14, 2024

Class III

Product summary

Firm
Ortho-Clinical Diagnostics, Inc.
Event
Event 94734
Status
Ongoing
Classification
Class III
Quantity
1718
Official record key
device-enforcement:Z-2245-2024

Official wording

Reason: 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.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.