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VIDAS TOXO IGG AVIDITY (2016-08-09)
- Starting date:
- August 9, 2016
- Posting date:
- August 26, 2016
- 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-59974
Affected Products
VIDAS TOXO IGG AVIDITY
Reason
Invalid results on VIDAS Toxo IgG avidity (ref. 30222) may occur when it is necessary to bring the sample titer to theoretical 15 ui/ml. This issue can occur when applying an inappropriate dilution factor when testing the sample on VIDAS Toxo IgG avidity, which leads to invalid results. This issue cannot lead to false results on VIDAS Toxo IgG avidity.
Affected products
VIDAS TOXO IGG AVIDITY
Lot or serial number
- 1004563050
- 1004728260
- 1004863430
Model or catalog number
30 222
Companies
- Manufacturer
-
Biomerieux Sa
Chemin De L'orme
Marcy-l'etoile
69280
FRANCE