Z-2245-2024Class III

VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry...

Name: Z-2245-2024 VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2024-05-14
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-05-14 / Open, Classified / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of 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... on 2024-05-14. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2245-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-05-14
Posted: 2024-07-01
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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
Product code: JMO Ferrozine (Colorimetric) Iron Binding Capacity
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: (UDI/GTIN# 10758750002672; Lot Number 2953; Expiration Date: 24-Jul-2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2245-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2245-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-01

Product code JMO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)