Health product recall

cobas® c 303 analytical unit

Last updated

Summary

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

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.

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
Recall class
Type II
Recall date
Identification number
RA-82785

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