CATSmart (2019-04-11)

Starting date:

April 11, 2019

Posting date:

April 18, 2019

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-69628

Last updated: 2019-04-18

• 
  Reason
• 
  Affected products

Affected Products

CATSmart

Reason

Worn out or leaking centrifuge tubes due to a multifaceted set of events involving the CATSmart systems (device, software and disposable) which may result in the centrifuge tubing line making contact with the washing chamber thereby causing excessive wear on the centrifuge tubing or in extreme cases a puncture of the tubing. 1) The centrifuge tubing line being within specification but not at its nominal length and/or 2) combined with priming acceleration parameters of the CATSmart device.

Affected products