This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM ANALYZERS (2015-07-30)
- Starting date:
- July 30, 2015
- Posting date:
- September 8, 2015
- 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-54924
Affected Products
A. BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - AU680 INSTRUMENT
B. BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - AU480 ANALYZER
C. BECKMAN COULTER AU5800 CLINICAL CHEMISTRY ANALYZER
Reason
In March 2011, the material and molding process of the coolant cup (C cups) was changed. Since the change, Beckman Coulter has received complaints regarding leaking and cracked C cups. When this occurs, coolant can leak onto and damage one of the printed circuit boards (PCBS) in the analyzers.
Affected products
A. BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - AU680 INSTRUMENT
Lot or serial number
>10 numbers, contact mfg.
Model or catalog number
AU680
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
B. BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - AU480 ANALYZER
Lot or serial number
>10 numbers, contact mfg.
Model or catalog number
AU480
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
C. BECKMAN COULTER AU5800 CLINICAL CHEMISTRY ANALYZER
Lot or serial number
>10 numbers, contact mfg.
Model or catalog number
AU5810
AU5820
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES