Lower risk Medical device recall · FDA · Published December 19, 2024

VITROS XT 7600 System Software 3.8.0 May Not Detect Expired Reagents

Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated Systems with software version 3.8.0 or higher that may not alert users when reagent packs expire, risking incorrect test results.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1006-2025Medical device VITROS ›

Lower-risk recall

The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

Take action

Contact the company

Recalling firmOrtho-Clinical Diagnostics, INc.513 Technology Blvd · Rochester, NY 14626-3601

✎ GovInfoNow plain-language explainer

Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated Systems with software version 3.8.0 or higher. These systems might not warn users when reagent packs expire, which could lead to using expired products and causing inaccurate test results. Read more at govinfonow.com/recall/53226-vitros-xt-7600-system-software-3-8-0-may-not.

Source Summary by GovInfoNow · govinfonow.com/recall/53226-vitros-xt-7600-system-software-3-8-0-may-not · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1006-2025

Cite this page

“VITROS XT 7600 System Software 3.8.0 May Not Detect Expired Reagents.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53226-vitros-xt-7600-system-software-3-8-0-may-not. Based on FDA recall #Z-1006-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1006-2025%22&limit=1).

The FDA announced on Dec. 19, 2024, that Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated Systems with software version 3.8.0 or higher due to a hazard involving expired reagent packs. The agency said the software may not notify users if the Signal Reagent Pack exceeds its expiration date.

How to tell if you have it

Brand: VITROS
Product Name: VITROS XT 7600 Integrated System
Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China)
Software Version: version 3.8.0 or higher
Serial Numbers: 76000001-76002199
Manufacture Date Range: July 2018 to present
Distribution: Worldwide, including US Nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom

The hazard

The software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics has 53 other recalls on record since July 10, 2017. Other recent recalls include Ortho-Clinical VITROS 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 Healthmark ProChek-II: False Test Results Due to Expired Ingredient (July 29, 2026), Cook Staged Extubation Set: Expiration Dates Exceed Shelf Life (March 5, 2026), and Copan Italia DTT Liquid Reagent Recall (Oct. 29, 2025).

How to tell if you have this one

Check for VITROS XT 7600 Integrated Systems with model numbers 6844461 (New), 6272222 (Certified), or 6904003 (China). The software version should be 3.8.0 or higher. Systems were distributed from July 2018 to present.

Brand
VITROS
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-1005-2025	Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component; Lot Code: VITROS 5600 Integrated System (New) Product Code: 6802413 UDI: 10758750002740 VITROS 5600 Integrated System (Certified/Refurbished) Product Code: 6802915 UDI: 10758750002740 Lot Code: VITROS 5600 Integrated System (China) Product Code: 6904001 UDI: 10758750035786 Range of installed serial numbers: 56000015-56004962 Manufacture date range: August 2008 to present Distribution date range; August 2008 to present Total systems currently installed in the US: 905 Total systems currently installed outside the US:2344 Note1: The catalogue number 6802413 is used to denote the VITROS 5600 Integrated System. Catalogue number 6802415 is used to denote those VITROS 5600 Integrated Systems that have been refurbished, these systems can also be referred to as certified. A VITROS 5600 Integrated System maintains its original serial number through the refurbishment/certification process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined. Note2: When manufactured the system s serial numbers are sequential, but not all analyzers are released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum and maximum in serial numbers associated with all currently installed systems. Therefore, the amount of each system manufactured may not equal the amount of each system installed. Additionally, not all serial numbers listed are associated with an active installed analyzer in use today. Note3: The value given for "Product Quantity Distributed" is the total number of active installed systems that are in use today. This number is known to fluctuate as individual systems are installed and/or decommissioned.	3,249 units (905 US, 2,344 OUS)
Z-1006-2025	Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component; Lot Code: VITROS XT 7600 Integrated System Product Code: 6844461 (New) UDI: 10758750012343 VITROS XT 7600 System (Certified) Product Code: 6272222 UDI: 10758750012343 Lot Code: VITROS XT 7600 Integrated System Product Code: 6904003 (China) UDI: 10758750035809 Range of installed serial numbers:76000001-76002199 Manufacture date range: July 2018 to present Distribution date range; July 2018 to present Total systems currently installed in the US: 994 Total systems currently installed outside the US: 899 Note1: The catalogue number 6844461 is used to denote the VITROS XT 7600 Integrated System. Catalogue number 6272222 is used to denote VITROS XT 7600 System Certified. A VITROS XT 7600 Integrated System maintains its original serial number through the certification process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined. Note2: When manufactured the system s serial numbers are sequential, but not all analyzers are released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum and maximum in serial numbers associated with all currently installed systems. Therefore, the amount of each system manufactured may not equal the amount of each system installed. Additionally, not all serial numbers listed are associated with an active installed analyzer in use today. Note3: The value given for "Product Quantity Distributed" is the total number of active installed systems that are in use today. This number is known to fluctuate as individual systems are installed and/or decommissioned.	1,893 units (994 US, 899 OUS)
Z-1007-2025	Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component; Lot Code: VITROS 3600 Immunodiagnostic System Product Code: 6802783 (New) UDI: 10758750002979 VITROS 3600 Immunodiagnostic System (Certified/Refurbished) Product Code: 6802914 UDI: 10758750002979 VITROS 3600 Immunodiagnostic System (China) Product Code: 6904000 UDI: 10758750035779 Range of installed serial numbers:36000004-36001776 Manufacture date range: June 2008 to present Distribution date range; June 2008 to present Total systems currently installed in the US: 99 Total systems currently installed outside the US: 882 Note1: The catalogue number 6802783 is used to denote the VITROS 3600 Immunodiagnostic System. Catalogue number 6802914 is used to denote the VITROS 3600 Immunodiagnostic System that have been refurbished, these systems can also be referred to as certified. A VITROS 3600 Immunodiagnostic System Certified/Refurbished maintains its original serial number through the refurbishment/certification process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined. Note2: When manufactured the system s serial numbers are sequential, but not all analyzers are released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum and maximum in serial numbers associated with all currently installed systems. Therefore, the amount of each system manufactured may not equal the amount of each system installed. Additionally, not all serial numbers listed are associated with an active installed analyzer in use today. Note3: The value given for "Product Quantity Distributed" is the total number of active installed systems that are in use today. This number is known to fluctuate as individual systems are installed and/or decommissioned.	981 units (99 US, 882 OUS)

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your VITROS XT 7600 Integrated System. If it is 3.8.0 or higher, it is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore,…” 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 41 days after the firm started it.

Dec 19, 2024Firm started the recall
Jan 21, 2025FDA classified it Class II
Jan 29, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53226-vitros-xt-7600-system-software-3-8-0-may-not">VITROS XT 7600 System Software 3.8.0 May Not Detect Expired Reagents (GovInfoNow)</a>

Where this comes from

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-1006-2025 (December 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1006-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.