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Immage Low Concentration Immunoglobulin M (ILCIgM) (2014-02-10)
- Starting date:
- February 10, 2014
- Posting date:
- March 21, 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-38479
Recalled Products
Immage Low Concentration Immunoglobulin M (IGMLC)
Reason
Beckman Coulter has confirmed customer complaints regarding image IGMLC reagent lot number M205001. Customers have reported that they have received incorrect results of "greater than 60 mg/L" with an ORHI E65 error message for CSF patient samples which have a true concentration of 1.0 mg/L or less.
Affected products
Immage Low Concentration Immunoglobulin M (IGMLC)
Lot or serial number
447470
Model or catalog number
M205001
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES