Beckman Coulter DxC 500i and 500 AU Analyzers Recalled in Canada 2026

Health Canada has published a Type II recall for the DxC 500i Clinical Analyzer and the DxC 500 AU Clinical Chemistry Analyzer, both made by Beckman Coulter, Inc. The recall carries identification number RA-82863, carries a recall date of 2026-10-15, and was posted to the government recalls website on 2026-10-26.

The notice is aimed at healthcare audiences, not general consumers. It concerns laboratory equipment used for clinical chemistry testing, and the issue is classified under medical devices performance.

Regulatory Response

Health Canada lists the action as a health product recall in the category of medical devices – chemistry. The recall class is Type II. The notice was published by Health Canada, and the manufacturer listed is Beckman Coulter, Inc., based in Brea, California, in the United States.

The agency’s notice is short and does not describe patient harm or report any injuries. It focuses on a specific software behavior that laboratory operators need to understand.

The Reason Behind the Recall

According to the notice, Beckman Coulter determined that a modification made by operators to 25 predefined calculated rules will revert to the default expression following parameter package or software upgrades. These 25 calculated rules are included as part of the parameter package supplied with the analyzers.

In practical terms, if a laboratory has customized any of these rules, that customization will not carry through an upgrade. After a parameter package or software upgrade, the rule goes back to its default expression. A laboratory that does not notice the change could end up running a rule that no longer matches the settings it had chosen.

The notice does not say which of the 25 rules are affected most, and it does not describe specific clinical consequences. Laboratories that want more detail are directed to the manufacturer.

Products Affected by This Recall

Five product listings are named in the Health Canada notice. For each, the lot or serial number field reads 1.5 or lower.

• DxC 500 AU Clinical Chemistry Analyzer – model or catalogue number C63520
• DxC 500 AU Clinical Chemistry Analyzer – model or catalogue number C63519
• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module – model or catalogue number C63521
• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module – model or catalogue number C63522
• DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module – model or catalogue number C13252

The notice does not state how many units are affected in Canada.

Who Should Be Concerned

The stated audience for this recall is healthcare. That means hospital laboratories, clinical laboratories and other facilities that operate the listed Beckman Coulter analyzers are the main parties affected. Members of the public do not use this equipment directly, and nothing in the notice asks patients to take action.

Laboratory managers and technical staff should check which models and which version they are running. The notice lists 1.5 or lower in the lot or serial number field, so any system matching one of the five catalogue numbers should be reviewed against that entry.

What Consumers Need to Do Now

The only action listed on the Health Canada page is for affected facilities to contact the manufacturer if they require additional information. The notice does not publish a phone number, email address or a specific remedy such as a software patch or replacement.

• Identify whether your facility uses any of the five listed catalogue numbers.
• Check the version of your system against the 1.5 or lower entry in the notice.
• Review whether operators have modified any of the 25 predefined calculated rules.
• Contact Beckman Coulter, Inc. for additional information about next steps.

Anyone with a health or safety concern related to a health product can also use the report form linked from the Health Canada recalls page.

From the Agency

Health Canada’s notice states the issue plainly: Beckman Coulter has determined that a modification made by operators to 25 predefined calculated rules, included as part of the parameter package, will revert to the default expression following parameter package or software upgrades. The agency’s guidance to the audience is to contact the manufacturer if additional information is needed.

Quick Facts

• Recall number: RA-82863
• Recall class: Type II
• Recall date: 2026-10-15
• Posted: 2026-10-26
• Manufacturer: Beckman Coulter, Inc., Brea, California
• Audience: Healthcare

Because the notice is brief, laboratories should rely on direct communication from the manufacturer for the full instructions. Updates to the recall, if any, would be posted on the Health Canada recalls and safety alerts website.