Cobas e411 Immunoassay Analyzer (2018-09-24)

Starting date:

September 24, 2018

Posting date:

October 19, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67948

• 
  Reason
• 
  Affected products

Affected products

Cobas e411 Immunoassay Analyzer

Reason

Following investigation of customer complaints, the manufacturer changed the frequency interval for mandatory replacement of pinch valve tubing in order to avoid the risk to obtain potential too high results or out of the measuring range results.

Affected products