Unicel DxC 600i Clinical Analyzer (2017-03-13)

Starting date:

March 13, 2017

Posting date:

March 31, 2017

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-62856

• Reason
• Affected products

Affected Products

1. Unicel DxC 600i Synchron Access Clinical Analyzer
2. Access Immunoassay System - Analyzer Class 3
3. Access System Access 2 Analyzer - Class 2
4. Access2 Immunoassay System

Reason

Beckman Coulter has confirmed through internal investigation that the access reaction vessel (RV) lots listed fail to meet a specification for outside diameter on the open ended side of the RV.
- The RV lots listed may cause aliquot vessel (AV) shuttle motion errors when they are loaded onto the Unicel DXC 600i Synchron Access Clinical System through the closed tube aliquotter (CTA). There is no impact to patient results.
- Internal testing did not demonstrate shuttle motion errors on the access 2 standalone system.

Affected products