Platelet Aggregation Kit (2018-06-01)

Starting date:

June 1, 2018

Posting date:

July 5, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67168

• 
  Reason
• 
  Affected products

Affected products

Platelet Aggregation Kit

Reason

Particulate matter or microbial growth is present in some collagen vials; therefore, quality specifications are not fully met. Voluntary recall is being initiated as a precautionary measure as there is no functional issue and no associated risk of adverse health consequences with these lots.

Affected products