IMMAGE Immunochemistry System (2020-04-29)
- Starting date:
- April 29, 2020
- Posting date:
- May 15, 2020
- 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-73115
Last updated: 2020-05-15
Affecetd Products
- IMMAGE Immunochemistry System C3 Complement C3 Reagent
- IMMAGE Immunochemistry System C4 Complement C4 Reagent
- IMMAGE Immunochemistry System HPT Haptoglobin Reagent
- IMMAGE Immunochemistry System IGA Immunoglobulin A Reagent
- IMMAGE Immunochemistry System IGM Immunoglobulin M Reagent
Reason
Beckman Coulter has identified that IMMAGE C3, C4, HPT, IGA, and IGM reagents fail to meet IFU interference claims at high levels of lipid (triglycerides).
Affected products
A. IMMAGE Immunochemistry System C3 Complement C3 Reagent
Lot or serial number
- All lots.
Model or catalog number
- 446450
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. IMMAGE Immunochemistry System C4 Complement C4 Reagent
Lot or serial number
- All lots.
Model or catalog number
- 446490
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. IMMAGE Immunochemistry System HPT Haptoglobin Reagent
Lot or serial number
- All lots.
Model or catalog number
- 446480
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
D. IMMAGE Immunochemistry System IGA Immunoglobulin A Reagent
Lot or serial number
- All lots.
Model or catalog number
- 446460
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
E. IMMAGE Immunochemistry System IGM Immunoglobulin M Reagent
Lot or serial number
- All lots.
Model or catalog number
- 447610
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES