أجهزة طبية
cobas® c 303 analytical unit
Summary
| Type | Health product recall |
|---|---|
| Product | cobas® c 303 analytical unit |
| Issue | Medical devices - Performance |
| What to do | Roche Care Center at 1-877-273-3433, via navify®/Online Support and also by e-mail at laval.techinfo@roche.com. |
| Audience | Healthcare |
| Brand(s) | ROCHE DIAGNOSTICS GMBH |
| Last updated | 2026-10-15 |
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
cobas® c 303 analytical unit |
Not applicable. |
09031529001 |
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.
Details
| Original published date | 2026-10-15 |
|---|---|
| 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 |
| Recall class | Type II |
| Recall date | 2026-10-24 |
| Identification number | RA-82785 |
Source: Government of Canada, Recalls and safety alerts – https://recalls-rappels.canada.ca/en/alert-recall/cobasr-c-303-analytical-unit