Recall MonitorHealth Products
cobas® pro and cobas® pure
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: cobas® pro and cobas® pure
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| cobas® c 303 analytical unit | versions < 01-04 | 09031529001 |
| cobas® pro sample supply unit | versions < 03-01 | 08464502001 |
| cobas® pro sample supply unit | versions < 03-01 | 09205632001 |
| cobas® pure sample supply unit | versions < 01-04 | 09031537001 |
| cobas® c 503 analytical unit | versions < 03-01 | 08463662001 |
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.