IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent (2019-04-21)
- Starting date:
- April 21, 2019
- Posting date:
- June 28, 2019
- 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-70327
Last updated: 2019-06-28
Affected Products
IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent
Reason
Patient samples tested with IgM reagent lots M803185 and M806164 may generate E60 (no reaction, antigen excess failed) or E66 (unstable reaction) error messages on very low concentration samples.
Affected products
IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent
Lot or serial number
M803185
M806164
Model or catalog number
447610
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES