Health Canada Orders Class II Recall of Beckman Coulter iQ200, DxU Analyzers

Health Canada has classified a recall of Beckman Coulter Ireland Inc.’s iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers as a Class II health product recall, following customer complaints of internal fluid leaks that can pose physical, mechanical, or chemical hazards in laboratory settings.

The recall, identified under reference number RA-82520, was dated 2026-08-05 and published by Health Canada on 2026-08-21. It affects a range of laboratory analyzers used in clinical chemistry and urinalysis testing, all manufactured by Beckman Coulter Ireland, Inc. of Lismeehan, Co. Clare, Ireland.

Products Affected by This Recall

The recall covers five distinct analyzer models identified by their catalogue numbers. These include the ‘DxU 840m Iris’ (catalogue number C76947), the ‘iQ200 SPRINT 2008 Tested’ (700-3325), the ‘iQ200 SELECT 2008 Tested’ (700-3345), the ‘DxU 850m Iris’ (C49513), and the ‘iQ200 ELITE 2008 Tested’ (700-3375). According to Health Canada’s notice, more than ten lot or serial numbers are affected across these units, and facilities are advised to contact the manufacturer directly to confirm whether their specific units are included.

What Went Wrong?

Beckman Coulter received customer complaints describing lamina fluid leaks occurring in both the iQ200 Series and DxU 840m/850m Analyzers. A subsequent investigation traced the issue to a structurally compromised rinse-line check valve. This component defect can allow fluid to migrate internally within the device and ultimately leak onto surrounding surfaces, such as the lab table or floor, where it presents a risk of exposure to physical, mechanical, or chemical hazards for laboratory personnel.

The affected analyzers fall under Health Canada’s chemistry category of medical devices and are used primarily in healthcare and diagnostic laboratory environments, meaning the intended audience for this alert is healthcare professionals rather than the general public.

Who Is Affected?

This recall is directed at healthcare facilities, clinical laboratories, and diagnostic centres in Canada that operate any of the listed iQ200 or DxU model analyzers. Because the notice specifies that more than ten lot or serial numbers are implicated, facilities cannot rely on visual inspection alone and are urged to check their equipment records against the manufacturer’s information.

The recall does not appear to involve direct patient contact with the leaking fluid, but the potential for physical, mechanical, or chemical exposure means lab technicians and equipment operators working near these analyzers should treat the notice seriously.

What Should You Do?

Health Canada’s guidance is direct: facilities and users who require additional information should contact the manufacturer, Beckman Coulter Ireland, Inc. Given the volume of lot numbers involved, the company is best positioned to confirm which specific units and serial numbers at a given site fall under the recall.

• Locate the model or catalogue number of your analyzer and compare it against the list above.
• Contact Beckman Coulter directly for lot or serial number verification, since the affected list exceeds ten entries and is not published in full.
• Report any observed fluid leakage from the rinse line to the manufacturer and follow any interim handling instructions provided.
• Monitor Health Canada’s recall page for further updates, as the notice was last modified on 2026-08-21.

Official Statement

In its official notice, Health Canada stated that Beckman Coulter received customer complaints of lamina fluid leaks in the iQ200 Series and DxU 840m/850m Analyzers, and that the investigation found a structurally compromised rinse-line check valve may allow fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical, mechanical, or chemical hazards.

The recall has been formally logged as a Type II recall class under Health Canada’s medical devices program, with the case file listed under identification number RA-82520. No additional public remedy instructions, such as a refund or replacement program, were specified beyond directing affected facilities to the manufacturer for further information.