Health product recall

Access 2 Immunoassay System (2020-02-11)

Starting date:
February 11, 2020
Posting date:
March 13, 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-72537

Last updated: 2020-03-13

Affected Products

  1. Access Immunoassay System - Analyzer Class 3
  2. Access System Access 2 Analyzer - Class 2
  3. Access 2 Immunoassay System

Reason

Beckman Coulter has determined through customer feedback and an internal investigation that Access 2 Instrument version 3.6.0 software upgrade kits may fail to install, potentially causing instrument downtime.

Affected products

  1. Access Immunoassay System - Analyzer Class 3

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 386220
  • 81600N
Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES

B. Access System Access 2 Analyzer - Class 2

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

386220
81600N

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES

C. Access 2 Immunoassay System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

81600N

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES