Public recall detail

cobas® c 303 analytical unit

2026-10-15

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Health products Health product recall
Quick summary

Quick summary: cobas® c 303 analytical unit. Reason: Health product recall. Category: Health products. Date: 2026-10-15.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: cobas® c 303 analytical unit. Reason: Health product recall. Category: Health products. Date: 2026-10-15.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandROCHE DIAGNOSTICS GMBH
Productcobas® c 303 analytical unit
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82785

Affected products

Productcobas® c 303 analytical unit
LotNot applicable.
Model09031529001
Serial numberNot applicable.
Descriptioncobas® c 303 analytical unit

Issue

An issue has been identified where vacuum tubing of the cell rinse unit of the cobas c 303 analytical unit prematurely deteriorated. Investigations confirmed the issue. In the event of small pinholes or cracks, no impact on analytical performance was identified. However, in case of tubing rupture, the following can occur as a result of the issue: Undetected leakage: Fluid may drip into random reaction cells. Result impact: Increased risk of erroneous patient and QC results.

What you should do

  • Roche Care Center at 1-877-273-3433, via navify®/Online Support and also by e-mail at laval.techinfo@roche.com.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesRoche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, Germany, 68305
Recall date2026-10-24
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82785
Background{}
CompaniesRoche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, Germany, 68305
AudiencesHealthcare
Source updated2026-10-15

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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