Recall Monitor
Health Products

cobas® c 303 analytical unit

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
cobas® c 303 analytical unitNot 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.

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