IMMAGE IMMUNOCHEMISTRY SYSTEM PAB, APB & LPAX (2021-02-23)
- Starting date:
- February 23, 2021
- Posting date:
- March 11, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-75101
Last updated:
2021-03-11
Affected Products
A. IMMAGE IMMUNOCHEMISTRY SYSTEM PAB PREALBUMIN REAGENT
B. IMMAGE IMMUNOCHEMISTRY SYSTEM APB APOLIPOPROTEIN REAGENT
C. IMMAGE LIPOPROTEIN(A) (LPAX) REAGENT
Reason
Beckman Coulter has identified that IMMAGE APB, LPAX, and PAB reagents fail to meet their respective IFU lipid interference claims.
Affected products
A. IMMAGE IMMUNOCHEMISTRY SYSTEM PAB PREALBUMIN REAGENT
Lot or serial number
All lots.
Model or catalog number
447440
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. IMMAGE IMMUNOCHEMISTRY SYSTEM APB APOLIPOPROTEIN REAGENT
Lot or serial number
All lots.
Model or catalog number
447730
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. IMMAGE LIPOPROTEIN(A) (LPAX) REAGENT
Lot or serial number
All lots.
Model or catalog number
447450
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES