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Architect I System - EBV VCA IgM controls (2014-05-14)
- Starting date:
- May 14, 2014
- Posting date:
- June 5, 2014
- 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-39825
Recalled Products
Architect I System - EBV VCA IgM controls
Reason
During stability testing a significant signal drop for the positive control of architect EBV VCA IgM control kit compared to the release results was recognized, indicating a loss in signal over time. Subsequent out of specification low results for the positive control of Architect EBV VCA IgM control kit was documented confirming above observation of a loss in signal over time.
Affected products
Architect I System - EBV VCA IgM controls
Lot or serial number
38938LI00
Model or catalog number
3P66-10
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY