Lower risk Medical device recall · FDA · Published January 22, 2024

Ortho-Clinical VITROS 5600 System Recall: Risk of Erroneous Test Results

Ortho-Clinical recalls VITROS 5600 Integrated Systems (new and refurbished) due to potential aspiration during sample processing, which may cause incorrect test results. Affected units have specific serial numbers and UDI/DI codes.

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

🇺🇸 FDA recall #Z-1221-2024Medical device Ortho-Clinical ›

Lower-risk recall

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous 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 new and refurbished VITROS 5600 Integrated Systems because a design flaw might cause sample containers to be aspirated during testing, leading to inaccurate test results. This affects laboratory equipment used for medical testing. Read more at govinfonow.com/recall/56281-ortho-clinical-vitros-5600-system-recall-risk-of-erroneous-test.

Source Summary by GovInfoNow · govinfonow.com/recall/56281-ortho-clinical-vitros-5600-system-recall-risk-of-erroneous-test · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1221-2024

Cite this page

“Ortho-Clinical VITROS 5600 System Recall: Risk of Erroneous Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56281-ortho-clinical-vitros-5600-system-recall-risk-of-erroneous-test. Based on FDA recall #Z-1221-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1221-2024%22&limit=1).

The FDA announced on Jan. 22, 2024, that Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a potential for aspiration during processing that may lead to erroneous test results. The recall covers both new and refurbished units distributed worldwide.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS 5600 Integrated System (New and Refurbished)
UDI/DI (New): 10758750002740
UDI/DI (Refurbished): 10758750007110
Serial Numbers: J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691 and J36001164 through J36001692 (inclusive)

The hazard

According to the FDA, the hazard is a potential for aspiration from an unintended sample container during sampling center processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. This issue may lead to erroneous test results.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Other recent recalls of similar products include Ortho-Clinical 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 Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13), Vivoo Test Strips Recall (2025-11-22), and Vivoo pH Test Recall (2025-11-22).

How to tell if you have this one

Check for the VITROS 5600 Integrated System with serial numbers listed in the recall notice. New units have UDI/DI code 10758750002740 and refurbished units have 10758750007110.

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 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-1220-2024	VITROS 3600 Immunodiagnostic System (New and Refurbished); Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (inclusive).	489 units (46 US, 443 OUS)
Z-1221-2024	VITROS 5600 Integrated System (New and Refurbished); UDI/DI: (New) 10758750002740, (Refurbished) 10758750007110; Serial Numbers: J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691 and J36001164 through J36001692 (inclusive).	1460 units (506 US, 954 OUS)
Z-1222-2024	VITROS XT7600 Integrated System; Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive).	1,720 units (834 US, 886 OUS)

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify if your system has a serial number from the list provided in the recall notice.

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 51 days after the firm started it.

Jan 22, 2024Firm started the recall
Mar 1, 2024FDA classified it Class II
Mar 13, 2024Published 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/56281-ortho-clinical-vitros-5600-system-recall-risk-of-erroneous-test">Ortho-Clinical VITROS 5600 System Recall: Risk of Erroneous Test Results (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-1221-2024 (January 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1221-2024 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.