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