CanadaThe cobas pro (c503) and cobas pure (c303) laboratory analyzers are affected; affected units include model/catalogue numbers 09031529001, 08464502001, 09205632001, 09031537001 and 08463662001. A rare software malfunction in the calibration library has been identified that can affect assays using spline-type calibration and occurs only with cobas pro software versions <03-01 or cobas pure software versions <01-04. Contact the manufacturer for additional information.
What's being recalled
Companies: Roche Diagnostics GmbH, Sandhofer Strasse 116, Mannheim, Germany, 68305.
How to identify it
Affected products: cobas® c 303 analytical unit; Lot or serial number: versions 01-04; Model or catalogue number: 09031529001
Affected products: cobas® pro sample supply unit; Lot or serial number: versions 03-01; Model or catalogue number: 08464502001
Affected products: cobas® pro sample supply unit; Lot or serial number: versions 03-01; Model or catalogue number: 09205632001
Affected products: cobas® pure sample supply unit; Lot or serial number: versions 01-04; Model or catalogue number: 09031537001
Affected products: cobas® c 503 analytical unit; Lot or serial number: versions 03-01; Model or catalogue number: 08463662001
The hazard
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 to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)