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Health product recall

Fastpack IP Vitamin D Immunoassay

Starting date:
July 5, 2017
Posting date:
July 18, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-64022

Reason

Results could not be reported due to fact that they were below assay range. However in these cases a result was expected.

Affected products

Fastpack IP Vitamin D Immunoassay

Lot or serial number

1701033-3P
1701033-4P
1701033-5P
1701033-6P

Model or catalog number

25000068

Companies

Manufacturer
Qualigen Inc.
2042 Corte del Nogal
Carlsbad
92011
California
UNITED STATES