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Immage Immunochemistry Systems Immunoglobulin G Reagent (IgG)
- Starting date:
- February 6, 2017
- Posting date:
- February 27, 2017
- 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-62392
Reason
Immage IgG Lot M610132A parameter card barcode does not include the "a" suffix encoded in the barcode.
The reagent cartridge barcode needed to pair with the parameter card includes the "a" suffix.
Lot number mismatch causes a "parameters not found" error upon reagent cartridge barcode read.
Input of parameters and reagent load is by barcode only. System is not capable of manual entry.
Affected products
Immage Immunochemistry Systems Immunoglobulin G Reagent (IgG)
Lot or serial number
M610132A
Model or catalog number
446400
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES