Ortho Clinical Diagnostics VITROS 5,1 FS Chemistry System Recall: Software Calibration Risk

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Contact the company & request your remedy

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Ortho Clinical Diagnostics is recalling its VITROS 5,1 FS Chemistry System clinical analyzers because software anomalies in version 3.1 or above could cause calibration failures. This might lead to inaccurate test results if the device is used without proper calibration.

Why it’s dangerous

The software anomaly in version 3.1 or above may cause the device to fail calibration, leading to inaccurate test results. This could impact the reliability of clinical chemistry tests performed by the device.

Who’s affected

Healthcare facilities using the VITROS 5,1 FS Chemistry System with software version 3.1 or above are affected. Laboratory staff and patients using the device for clinical testing are at risk of inaccurate results.

How to tell if you have this one

Check if your VITROS 5,1 FS Chemistry System has software version 3.1 or above. The product code is 6801890 and UDI is 10758750001644.

Brand
Ortho Clinical Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your VITROS 5,1 FS Chemistry System; if it is 3.1 or above, it is affected.

✎ GovInfoNow

Questions people ask

What software version is affected?

Software version 3.1 or above.

How can I tell if my VITROS system is affected?

Check the software version; if it is 3.1 or above, it is affected. The product code is 6801890 and UDI is 10758750001644.

What should I do if my VITROS system is affected?

The recall does not specify a remedy, so contact Ortho Clinical Diagnostics for further instructions.

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-2184-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics

Hello,

I own a Ortho Clinical Diagnostics that is covered by recall Z-2184-2019 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-2184-2019 (July 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2184-2019 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 5,1 FS Chemistry System, clinical chemistry analyzer

Lower-risk recall