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VIDAS LYME IGG II (2016-03-14)
- Starting date:
- March 14, 2016
- Posting date:
- April 4, 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-57772
Affected Products
VIDAS LYME IGG II
Reason
Some customers reported that they could not perform calibration. Results of investigation reveal that calibration cannot be performed due to S1 RFV signal which triggers "invalid calibration" error.
Affected products
VIDAS LYME IGG II
Lot or serial number
- 1004127190
Model or catalog number
- 417401
Companies
- Manufacturer
-
Biomerieux Sa
Chemin De L'orme
Marcy-l'etoile
69280
FRANCE