COBAS 6500 ANALYZER (2021-05-26)

Starting date:

May 26, 2021

Posting date:

June 10, 2021

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-75785

Last updated:
2021-06-10

• 
  Reason
• 
  Affected products

Affected Products 

A. COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER

B. COBAS 6500 - COBAS U701 MICROSCOPY ANALYZER

Reason

Our manufacturer confirmed that, under rare circumstance, possible sample mismatch may occur while using the cobas u 701 microscopy analyzer in combination with cobas u 601 urine analyzer with software version 2.3.6. In case of asymptomatic patients (e.g. microhematuria), medical decisions may be affected if a result is incorrectly positive or negative. Therefore, a medical risk for the population at greatest risk cannot be excluded. This issue impacts only customers using cobas u601 in combination with cobas u701. Standalone instruments (cobas u601 used alone) are not impacted by the issue.

Affected products