Lower risk Medical device recall · FDA · Published July 19, 2022

Ortho-Clinical VITROS XT 7600 System Recall: Incorrect Test Results Risk

Ortho-Clinical recalls VITROS XT 7600 systems with software version 3.7.2 or older. These systems may report inaccurate test results due to electrical current shifts in the LED. Affected units have product code 6844461.

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

🇺🇸 FDA recall #Z-1676-2022Medical device Ortho-Clinical ›

Lower-risk recall

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

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 laboratory analyzers with software version 3.7.2 or older. The recall happens because these systems might give incorrect test results due to electrical current shifts in the LED. This could affect medical testing accuracy. Read more at govinfonow.com/recall/60346-ortho-clinical-vitros-xt-7600-system-recall-incorrect-test-results.

Source Summary by GovInfoNow · govinfonow.com/recall/60346-ortho-clinical-vitros-xt-7600-system-recall-incorrect-test-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1676-2022

Cite this page

“Ortho-Clinical VITROS XT 7600 System Recall: Incorrect Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60346-ortho-clinical-vitros-xt-7600-system-recall-incorrect-test-results. Based on FDA recall #Z-1676-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1676-2022%22&limit=1).

The FDA announced on July 19, 2022, that Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated Systems with Version 3.7.2 and below due to potential shifts in test results. The hazard stems from system shutdowns affecting the electrical current supplied to the Digital Imaging Reflectometer LED.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS XT 7600 Integrated System with Version 3.7.2 and below
Product Code: 6844461
UDI-DI: 10758750031610
System start codes: 7600XXXX where XXXX is unique for each analyzer

The hazard

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used with the Digital Imaging Reflectometer. This potential shift can result in either a positive or negative shift in results reported by the VITROS System.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. 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 Vivoo pH Test Recall (Nov. 22, 2025), Vivoo Vaginal pH Test Recall (Nov. 22, 2025), and Vivoo Test Strips Recall (Nov. 22, 2025).

How to tell if you have this one

Check the system's software version on the label. Affected units have product code 6844461 and start with the serial number 7600XXXX.

Brand
Ortho-Clinical
Category
Medical device

FDA recall event · 2 products

All 2 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 DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-1675-2022	VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458; UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer	506 units
Z-1676-2022	VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461; UDI-DI: 10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer	1148 units

Based on the official FDA remedy

What to do — step by step

Check Software Version
Look for the software version on the system label; affected units have version 3.7.2 or older.

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 DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, 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.

Jul 19, 2022Firm started the recall
Sep 2, 2022FDA classified it Class II
Sep 14, 2022Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More Ortho-Clinical recalls

Link to this recall

<a href="https://govinfonow.com/recall/60346-ortho-clinical-vitros-xt-7600-system-recall-incorrect-test-results">Ortho-Clinical VITROS XT 7600 System Recall: Incorrect Test Results Risk (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-1676-2022 (July 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1676-2022 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.