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LP(A) SPQ II Test System (August 16, 2013)

Report a Concern
Starting date:
August 16, 2013
Posting date:
August 16, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-35463

Reason

A shift in patient results on the high end of the calibration curve may occur due to a decrease in antibody activity. Shift is minor and would not impact the clinical interpretation of the results.

Affected products

LP(A) SPQ II Test System (2013-08-16)

Lot or serial number

128738, 129882

Model or catalog number

86084

Companies

Manufacturer
Not Applicable