Lower riskMedical device recall · FDA · Published May 14, 2024
Ortho-Clinical VITROS Calibrator Kit 29- In-Vitor: Expired Date Risk
Ortho-Clinical recalls VITROS Calibrator Kit 29- In-Vitor with incorrect expiration date (24-Jul-2024) that may cause inaccurate test results if not updated with Assay Data Disk.
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.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer
Ortho-Clinical is recalling VITROS Chemistry Products Calibrator Kit 29- In-Vitor due to an incorrect expiration date. Using this kit past its true expiration without updating the Assay Data Disk may cause inaccurate test results. The kit is currently within its use date and functions properly. Read more at govinfonow.com/recall/55116-ortho-clinical-vitros-calibrator-kit-29-in-vitor-expired-date.
“Ortho-Clinical VITROS Calibrator Kit 29- In-Vitor: Expired Date Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55116-ortho-clinical-vitros-calibrator-kit-29-in-vitor-expired-date. Based on FDA recall #Z-2245-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2245-2024%22&limit=1).
The FDA announced on May 14, 2024, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 29 due to an incorrect extended expiration date. This error may bias test results if the calibrator is used past its true expiration without an updated Assay Data Disk.
The kit was assigned an extended expiration date of July 24, 2025, instead of the correct date of July 24, 2024. If used past its true expiration and the customer does not have their Assay Data Disk updated, the system will allow them to use the expired calibrator which may bias the results.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics has 53 other recalls on record since July 10, 2017. Other recent recalls of similar products include Ortho-Clinical LAC Slides Recall (July 29, 2025), Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (June 12, 2025). Other recent recalls of similar products include Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation (May 13, 2026), Cook Staged Extubation Set (March 5, 2026), and Cerapedics PearMatrix P-15 Bone Graft Recall (December 29, 2025).
How to tell if you have this one
Check for the calibrator kit model 29- In-Vitor with lot number 2953 and expiration date 24-Jul-2024. It's used with VITROS 5,1 FS/4600 and VITROS 5600/XT 7600 systems for iron-binding capacity testing.
Brand
Ortho-Clinical
Product
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Assay Data Disk
Update the Assay Data Disk if the calibrator kit has expired to prevent inaccurate test results.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2245-2024 (May 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2245-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.