VITROS 5600 Integrated System (2018-08-20)

Starting date:

August 20, 2018

Posting date:

August 31, 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-67638

• 
  Reason
• 
  Affected products

Affected products

VITROS 5600 Integrated System

Reason

Under very specific circumstances, incorrect positioning of the sample metering proboscis on a VITROS 5600 Integrated System may cause an insufficient sample volume to be dispensed onto a microslide without suppressing the potentially incorrect result. If these specific circumstances occur, the proboscis may deposit fluid on the tip locator or top surface of the slide and transfer sample fluid into the incubator. Mis-positioning of the proboscis may lead to an insufficient volume of sample being dispensed onto a microslide and may lead to incorrect results.

Affected products