Lower risk Medical device recall · FDA · Published May 9, 2025

Ortho-Clinical VITROS XT 7600 System: Software error causes false expired reagent warnings

Ortho-Clinical recalls VITROS XT 7600 Integrated Systems with software versions 3.2 to 3.8.3 due to false expired reagent warnings that can cause inaccurate test results.

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

🇺🇸 FDA recall #Z-2039-2025Medical device Ortho-Clinical ›

Lower-risk recall

a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

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 XT 7600 Integrated Systems with specific model numbers and software versions because a software issue causes the system to incorrectly flag reagent packs as expired even when they are not. This can lead to inaccurate test results or delays in processing tests. Read more at govinfonow.com/recall/52316-ortho-clinical-vitros-xt-7600-system-software-error-causes-false.

Source Summary by GovInfoNow · govinfonow.com/recall/52316-ortho-clinical-vitros-xt-7600-system-software-error-causes-false · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2039-2025

Cite this page

“Ortho-Clinical VITROS XT 7600 System: Software error causes false expired reagent warnings.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52316-ortho-clinical-vitros-xt-7600-system-software-error-causes-false. Based on FDA recall #Z-2039-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2039-2025%22&limit=1).

The FDA announced on 2025-05-09 that Ortho-Clinical Diagnostics, Inc. is recalling VITROS XT 7600 Integrated Systems due to a software anomaly that can cause erroneous or delayed test results. The recall affects systems with serial numbers ranging from 76000109 to 76002327.

How to tell if you have it

Brand: Ortho-Clinical
Product Name: VITROS XT 7600 Integrated System
Model/Catalog Number: 6844461
Model/Catalog Number: 6272222
Serial numbers: 76000109-76002327

The hazard

A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. This issue was identified by a customer complaint in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. The anomaly can result in erroneous test results and/or delaying test results.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Recent similar recalls include Ortho-Clinical VITROS LAC Slides Recall (2025-07-29), Ortho-Clinical VITROS Ca Slides Recall (2025-07-09), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (2025-06-12). Other recent recalls of similar products include Healthmark ProChek-II: False Test Results Due to Expired Ingredient (2026-07-29), BD Ready-to-Use Hydrophilic Catheter 14 Fr: Incorrect Expiration Date Labeling (2025-11-29), and Covidien EndoFLIP System: Catheters May Be Incorrectly Flagged as Expired (2026-05-13).

How to tell if you have this one

Check if your VITROS XT 7600 Integrated System has model numbers 6844461 or 6272222 and software versions 3.2 through 3.8.3. The system's serial numbers range from 76000109 to 76002327.

Brand
Ortho-Clinical
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 OUS (International) to 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-2038-2025	Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915; VITROS 5600 Integrated System; Product Code: 6802413; UDI: 10758750002740; VITROS 5600 Integrated System - Certified/Refurbished; Product Code: 6802915; UDI: 10758750002740; Range of installed serial numbers: 56000143-56005096 Note1: The catalogue number 6802413 is used to denote the VITROS 5600 Integrated System. Catalogue number 6802915 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.	3117 units (813 US, 2304 OUS)
Z-2039-2025	Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.; VITROS XT 7600 Integrated System; Product Code: 6844461; UDI: 10758750012343; VITROS XT 7600 System - Certified; Product Code: 6272222; UDI: 10758750012343; Range of installed serial numbers:76000109-76002327; Total systems currently installed in the US: 1,019 Total systems currently installed outside the US: 939 Total systems installed worldwide (Product Quantity Distributed): 1,958 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.	1958 units (1019 US, 939 OUS)
Z-2040-2025	Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.; VITROS 4600 Chemistry System; Product Code: 6802445; UDI: 10758750012343; VITROS 4600 Chemistry System - Refurbished; Product Code: 6900440; UDI: 10758750033201; Range of installed serial numbers:46000111-46001897; Manufacture date range: April 2011 to present Distribution date range; April 2011 to present Total systems currently installed in the US: 135 Total systems currently installed outside the US: 1,127 Total systems installed worldwide (Product Quantity Distributed): 1,262 Note1: The catalogue number 6802445 is used to denote the VITROS 4600 Chemistry System. Catalogue number 6900440 is used to denote VITROS 4600 Chemistry System- refurbished. A VITROS 4600 Chemistry System maintains its original serial number through the refurbishment 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.	1262 units (135 US, 1127 OUS)

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version by checking the device settings or documentation.
Update Software
Install the latest software update (version 3.8.3 or newer) to fix the issue.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal,…” 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 2 months after the firm started it.

May 9, 2025Firm started the recall
Jun 27, 2025FDA classified it Class II
Jul 9, 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/52316-ortho-clinical-vitros-xt-7600-system-software-error-causes-false">Ortho-Clinical VITROS XT 7600 System: Software error causes false expired reagent warnings (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-2039-2025 (May 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2039-2025 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.