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Monolisa Hcv Ag-Ab Ultra V2
- Starting date:
- March 8, 2017
- Posting date:
- March 31, 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-62854
Reason
An in-depth study showed a problem with the stability of conjugate 1 (R6). Drift in control and sample optical density over the useful life of the kit was observed.
Affected products
Monolisa Hcv Ag-Ab Ultra V2
Lot or serial number
- 6J0029
- 6J0533
- 6K0030
- 6K0031
- 6K0534
- 6K0535
- 6M0032
- 7A0033
Model or catalog number
- 72561
- 72562
Companies
- Manufacturer
-
Bio-Rad
3 BOULEVARD RAYMOND POINCARE
MARNES-LA-COQUETTE
92430
FRANCE