cobas® pro and cobas® pure
Brand(s)
Last updated
Summary
Product
cobas® pro and cobas® pure
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Roche Diagnostics GmbH
Sandhofer Strasse 116, Mannheim, Germany, 68305
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-81568
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