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Immage Immunochemistry Systems Rheumatoid Factor Reagent
- Starting date:
- November 29, 2012
- Posting date:
- December 24, 2012
- 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-25921
Recalled Products
- Immage Immunochemistry Systems Rheumatoid Factor Reagent
Reason
During Beckman Coulter Inc (BEC) internal real-time stability testing, some lots of RF reagent showed calibration failure before the currently labeled shelf life. Although some lots have passed real-time stability testing, to be conservative, the expiration dating of all in-date and in-process lots is being shortened.
Affected products
A. Immage Immunochemistry Systems Rheumatoid Factor Reagent
Lot or serial number
M008778, M103174, M106133, M108384,
M109226, M112118
Model or catalog number
447070
Companies
- Manufacturer
-
Beckman Coulter Inc.
7075 Financial Drive
Mississauga
L5N 6V8
Ontario
CANADA