Roche cobas c 303 Analytical Unit Recalled Over Tubing Defect: Health Canada

Health Canada has published a Type II recall for the cobas c 303 analytical unit, a chemistry analyzer made by Roche Diagnostics GmbH. The notice was issued on October 15, 2026 under identification number RA-82785. It is aimed at healthcare audiences, such as laboratories and facilities that use the instrument.

The recall concerns vacuum tubing in the analyzer’s cell rinse unit, which has been found to deteriorate prematurely. Roche’s investigations confirmed the problem.

Products Affected by This Recall

The recall covers one product:

• Product: cobas c 303 analytical unit
• Model or catalogue number: 09031529001
• Lot or serial number: Not applicable
• Manufacturer: Roche Diagnostics GmbH, Sandhofer Strasse 116, Mannheim, Germany
• Category: Medical devices – Chemistry

The notice does not say how many units are affected or give lot or serial numbers. Laboratories should use the catalogue number to check whether they operate the recalled model.

The Reason Behind the Recall

According to Health Canada, the vacuum tubing of the cell rinse unit can break down earlier than expected. The effect depends on how far the damage goes.

If the tubing develops only small pinholes or cracks, no impact on analytical performance was identified. If the tubing ruptures, two problems can follow:

• Undetected leakage: fluid may drip into random reaction cells.
• Result impact: there is an increased risk of erroneous patient and QC results.

The second problem is the more serious one. Laboratory results guide clinical decisions, and quality control (QC) results are used to confirm that an analyzer is working correctly. A leak that goes unnoticed and affects either kind of result could undermine confidence in the data the instrument produces.

Who Should Be Concerned

This is a healthcare-audience recall, not a consumer product recall. It is relevant to clinical laboratories, hospitals and other facilities in Canada that operate the cobas c 303 analytical unit, and to the staff who run it and review its results.

Health Canada classifies the action as a Type II recall. The notice gives the recall date as October 24, 2026. The listed country of the notice is Canada.

What Consumers Need to Do Now

The source gives one instruction: contact Roche. Facilities that use the affected analyzer can reach the manufacturer through any of these channels:

• Roche Care Center by phone at 1-877-273-3433
• navify or Online Support
• Email at laval.techinfo@roche.com

The notice does not describe a repair schedule, a replacement process or any interim operating guidance. Facilities should ask Roche about those directly. They should also tell the staff who run the analyzer about the issue and the possible effect on results.

Regulatory Response

The recall was published by Health Canada through its Recalls and Safety Alerts database, under the Medical devices category. The agency’s summary lists the issue as a medical device performance problem. Health Canada also encourages people to report health or safety concerns through its online reporting page. Anyone can subscribe to its recall email notifications.

Anyone seeking more detail should refer to recall RA-82785 on the Health Canada recalls website, or contact the Roche Care Center.

Quick Facts

• Recall number: RA-82785
• Recall class: Type II
• Issued by: Health Canada
• Company: Roche Diagnostics GmbH
• Model: 09031529001
• Issue: Vacuum tubing in the cell rinse unit deteriorating prematurely