Health product recall

Parvovirus B19 IgG ENZYME IMMUNOASSAY (2020-07-17)

Starting date:
July 17, 2020
Posting date:
August 14, 2020
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-73691

Last updated: 2020-08-14

Affected Products

Parvovirus B19 IgG ENZYME IMMUNOASSAY

Reason

Parvovirus B19 IgG EIA (Part V519IGUS, lot 71440040AA) contains the incorrect Lot Specific Constant value of 0.10 inside the box lid.

Affected products

Parvovirus B19 IgG ENZYME IMMUNOASSAY
Lot or serial number

71440040AA

Model or catalog number

V519IGUS

Companies
Manufacturer
Diasorin Inc.
1951 Northwestern Avenue, P.O. Box 285
Stillwater
55082
Minnesota
UNITED STATES