cobas e801 analyzer (2019-03-17)

Starting date:

March 17, 2019

Posting date:

March 26, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69418

• 
  Reason
• 
  Affected products

Affected Products

cobas e801 analyzer

Reason

Potential signal drops on some cobas 800 e801 modules (cat # 07682913001), due to degradation of ProCell II M in the flowpath, caused by bacterial contamination.

Affected products