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Health product recall

MicroVue Bb Plus EIA (2014-10-17)

Starting date:
October 17, 2014
Posting date:
October 27, 2014
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-41901

Recalled Products   

MicroVue Bb Plus EIA 

Reason

Some human plasma and human serum are quantitating incorrectly, with approximately 50% higher concentration valves than previously reported and historically documented.

Affected products

MicroVue Bb Plus EIA 

Lot or serial number

018186

Model or catalog number

A027

Companies
Manufacturer
Quidel Corporation,
10165 McKellar court,
San Diego
92121
California
UNITED STATES