Public recall detail

cobas® pro and cobas® pure

2026-02-04

medium
Recall Safety notice
Quick summary

Quick summary: cobas® pro and cobas® pure . Date: 2026-02-04.

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® pro and cobas® pure . Date: 2026-02-04.

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® pro and cobas® pure
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81568

Affected products

Productcobas® c 303 analytical unit
Lotversions 01-04
Model09031529001
Serial numberversions 01-04
Descriptioncobas® c 303 analytical unit
Productcobas® pro sample supply unit
Lotversions 03-01
Model08464502001
Serial numberversions 03-01
Descriptioncobas® pro sample supply unit
Productcobas® pro sample supply unit
Lotversions 03-01
Model09205632001
Serial numberversions 03-01
Descriptioncobas® pro sample supply unit
Productcobas® pure sample supply unit
Lotversions 01-04
Model09031537001
Serial numberversions 01-04
Descriptioncobas® pure sample supply unit
Productcobas® c 503 analytical unit
Lotversions 03-01
Model08463662001
Serial numberversions 03-01
Descriptioncobas® c 503 analytical unit

Issue

A rare software malfunction has been identified on the cobas® pro (c503) and cobas® pure (c303) platforms affecting the calibration library. This defect only occurs with cobas® pro software version <03-01 or cobas® pure software version <01-04. It can impact assays using spline-type calibration.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Chemistry
CompaniesRoche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, Germany, 68305
Recall date2026-01-23
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81568
Background{}
CompaniesRoche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, Germany, 68305
AudiencesHealthcare Industry
Source updated2026-02-04

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

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