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THROMBOTYPE 1 (2017-09-21)
- Starting date:
- September 21, 2017
- Posting date:
- October 20, 2017
- 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-64908
Affected products
THROMBOTYPE 1
Reason
As a result of a complaint investigation, Immucor determined that the ThromboType 1 kit, lot 3004507, has the potential to generate a failed assay or a sample mistype. The HPA-1b allele specific primer is experiencing low to no reactivity.
Affected products
THROMBOTYPE 1
Lot or serial number
3004507
Model or catalog number
THROMBOTYPE 1
Companies
- Manufacturer
-
Immucor GTI Diagnostics, Inc.,
20925 Crossroads Circle,
Waukesha
53186
Wisconsin
UNITED STATES