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Immage Immunochemistry Systems Apolipoprotein A-1 (APA) and Apolipoprotein Calibrator (Apo Cal) (2014-03-26)
- Starting date:
- March 26, 2014
- Posting date:
- April 22, 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-39165
Recalled Products
A. Immage Immunochemistry Systems Apolipoprotein A-1 (APA)
B. Apolipoprotein Calibrator (Apo Cal)
Reason
The Immage Immunochemistry system Apolipoprotein A-1 (APA) reagent lots M209295 and M305285 in combination with Apo Cal lots M210003 and M305133 may produce inaccurate results.
Affected products
A. Immage Immunochemistry Systems Apolipoprotein A-1 (APA)
Lot or serial number
M209295
M305285
Model or catalog number
446410
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Apolipoprotein Calibrator (Apo Cal)
Lot or serial number
M210003
M305133
Model or catalog number
469283
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES