Health product recall

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

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

ThromboType

Lot or serial number

3005154

Model or catalog number

THROMBOTYPE

Companies
Manufacturer
Immucor GTI Diagnostics, Inc.,
20925 Crossroads Circle,
Waukesha
53186
UNITED STATES