Health product recall

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