ThromboType (2018-07-05)

Starting date:

July 5, 2018

Posting date:

July 19, 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-67282

• 
  Reason
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  Affected products

Affected products

ThromboType

Reason

As a result of a stability failure at the 15month test point, ThromboType kit, Lot 3005154, has the potential to generate an incorrect result or no result with HPA-1 and/or HPA-3. The HPA-1a and HPA-3a allele specific primers for the affected ThromboType lot are experiencing low to no reactivity. OOS 18-98 was initiated to investigate weak and/or absent bands in HPA-1a and HPA-3a during the initial testing on 05/30/18. The failure mode observed in OOS 18-98 was confirmed during repeat testing on 06/11/18.

Affected products