Ortho-Clinical Diagnostics VITROS 4600 Software Anomaly Recall

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Contact the company & request your remedy

Recalling firmOrtho-Clinical Diagnostics100 Indigo Creek Dr · Rochester, NY 14626-5101

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System versions 3.3.1 and below. This software issue could cause reagents to stay stable longer than they should, potentially leading to inaccurate test results.

Why it’s dangerous

The software anomaly may incorrectly extend the on-analyzer stability time for loaded reagents. This could lead to reagents being used beyond their safe stability period, resulting in inaccurate test results.

Who’s affected

Healthcare facilities using the VITROS 4600 Chemistry System with software version 3.3.1 or below are affected. Laboratory staff and patients using these systems are at risk of inaccurate test results.

How to tell if you have this one

Check if your VITROS 4600 Chemistry System has software version 3.3.1 or below. Product code 6802445, UDI 10758750012343, and serial numbers J46000108-J46001132 are associated with this recall.

Brand
Ortho-Clinical Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your VITROS 4600 Chemistry System software version to see if it is 3.3.1 or below.

✎ GovInfoNow

Questions people ask

What is the software version that is recalled?

Software version 3.3.1 and below.

How can I check if my VITROS 4600 is affected?

Check the product code (6802445), UDI (10758750012343), or serial numbers (J46000108-J46001132) to confirm if your system is affected.

What should I do if I have the recalled software?

The recall record does not specify a remedy, so no action is required beyond checking your software version.

Take action

Contact Ortho-Clinical Diagnostics

We’ve drafted a message you can send Ortho-Clinical Diagnostics to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0653-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics

Hello,

I own a Ortho-Clinical Diagnostics that is covered by recall Z-0653-2019 from Ortho-Clinical Diagnostics.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0653-2019 (October 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0653-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Ortho-Clinical Diagnostics recalls VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of

Lower-risk recall