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VIDAS SYSTEM - TOXO IGM (TXM) ASSAY (2016-02-08)
- Starting date:
- February 8, 2016
- Posting date:
- April 7, 2016
- 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-57834
Affected products
A. VIDAS SYSTEM - TOXO IGM (TXM) ASSAY
Reason
An external study showed that performing tests with inactivated sera provides discrepant results. The index results obtained testing inactivated serum are lower compared to values obtained with fresh serum. This could lead for borderline sample to a drift in the overall result interpretation (i.e. from positive to equivocal, from equivocal to negative, from positive to negative).
Affected products
A. VIDAS SYSTEM - TOXO IGM (TXM) ASSAY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
30202
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
63042
Missouri
UNITED STATES