Ortho Clinical Diagnostics VITROS 3600 Software Recalls: Parameter Reset Risk

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Ortho Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System software versions 3.3.3 and below. This software may reset assay parameters, which could affect test accuracy if not properly maintained.

Why it’s dangerous

The software may reset microwell qualitative assay parameters to default settings under certain conditions. This could lead to inaccurate test results if the parameters are not retained properly.

Who’s affected

Users of the VITROS 3600 system with software versions 3.3.3 and below are affected. Laboratories that perform medical tests using this equipment are most at risk.

How to tell if you have this one

Check your VITROS 3600 system's software version. Affected units have product code 6802783 and serial numbers J36000109-J36001317.

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 3600 software version to see if it is 3.3.3 or below.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software versions 3.3.3 and below are affected.

What is the product code for the affected units?

Product code 6802783.

How can I check if my unit is affected?

Check the serial number range: J36000109-J36001317.

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-2480-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics

Hello,

I own a Ortho Clinical Diagnostics that is covered by recall Z-2480-2020 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-2480-2020 (May 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2480-2020 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.

Ortho Clinical Diagnostics recalls VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier:

Lower-risk recall