Cobus 6500 u601 Urinalysis System - Urine Analyzer and Cobus 6500 u701 Microscopy Analyzer (2018-01-15)

Starting date:

January 15, 2018

Posting date:

February 1, 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-65878

• 
  Reason
• 
  Affected products

Affected products

1. COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE
2. COBAS 6500 U701 MICROSCOPY ANALYZER

Reason

There is a potential sample mismatch that could occur between samples processed on the same rack on the Cobas 6500 u601 Urine Analyzer and/or Cobas u701 Microscopy Analyzer. The issue can occur if the sensors are misadjusted (either after transportation of the instrument or service has been performed on the sensor itself). There is no indication that the sensors can become misadjusted during operation. The analyzer may not transport the rack correctly, so that tubes might be detected twice. As a consequence, the same tube barcode label is read twice and the last tube barcode label is interpreted as the rack identification (ID). Hence, a sample mismatch is possible between samples processed on the same rack, because the tubes are pipetted in the order given by the rack position and the test result is assigned to the wrong sample ID.

Affected products