CanadaWhat'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: Not applicable.; Model or catalogue number: 09031529001
The hazard
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.
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.
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)