Laminin AB-1 100uL and Avidin Biotin-Blocking Sol (2013-10-21)

Starting date:

October 21, 2013

Posting date:

December 17, 2013

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-37177

• 
  Reason
• 
  Affected products

Recalled products

1. Laminin AB-1 100uL
2. Avidin Biotin-Blocking Sol

Reason

During a recent internal review of medical devices, it was discovered that two IVD (In Vitro Diagnosis) antibodies from Lab Viision were loaded into our system as Class I medical device which is sold and classified in the United States as Class I.  The Lab Vision antibodies which are classified as IVD are classified as medical device Class II in Canada. Since it was downloaded from the US system as Class I medical device, it was not being verified against Health Canada medical device licensing at the time.

Affected products