BD COR System Software Recall: False Negative Results Risk

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Contact the company & request your remedy

Recalling firmBecton Dickinson & Co.7 Loveton Cir, N/A · Sparks, MD 21152-9212

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Becton Dickinson is recalling software version 8.80 and above for the BD COR System Model 444:444829. This software could cause false negative results in testing, meaning some issues might not be detected properly.

Why it’s dangerous

The software may produce false negative results, meaning it could fail to detect certain issues during testing. This happens because of a problem with the 'Over labeling' feature in the software. False negatives can lead to incorrect conclusions in medical testing.

Who’s affected

Users of the BD COR System software version 8.80 or higher with model number 444829 are affected. Laboratory staff and healthcare professionals using this software for testing are most at risk.

How to tell if you have this one

Check for software version 8.80 or higher on the BD COR System with model number 444829. The UDI-DI code 00382904448295 is also associated with this recall.

Brand
Becton Dickinson
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your BD COR System software version is 8.80 or higher with model number 444829.

✎ GovInfoNow

Questions people ask

What software is being recalled?

Software version 8.80 and above for BD COR System Model 444829.

How can I tell if I have the recalled software?

Check for software version 8.80 or higher with model number 444829. The UDI-DI code 00382904448295 is also associated with this recall.

What should I do if I have the recalled software?

The recall does not specify a remedy, so contact Becton Dickinson for further instructions.

Take action

Contact Becton Dickinson

We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2162-2025 — Becton Dickinson Becton Dickinson

Hello,

I own a Becton Dickinson that is covered by recall Z-2162-2025 from Becton Dickinson.

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-2162-2025 (June 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2162-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.

Becton Dickinson & Co. recalls BD COR System Software. Model Number: 444829.

Lower-risk recall