Health product recall

UniCel DxC 600i Synchron Access Clinical Systems and UniCel DxC 600 Access Immunoassay System with Dual Gantry (Class 2 and Class 3) (2018-05-15)

Starting date:
May 15, 2018
Posting date:
May 25, 2018
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-66888

Affected products

  1. UniCel DxC 600i Synchron Access Clinical Systems
  2. UniCel DxC 600 Access Immunoassay System with Dual Gantry (Licence #75053, Class 2)
  3. UniCel DxC 600 Access Immunoassay System with Dual Gantry (Licence #77901, Class 3)

Reason

Beckman Coulter has determined the UniCel DxC Synchron Clinical Systems reference manual and Instructions For Use (IFU) have not been updated to include the ambient operating temperature requirements for the immunoassay analyzer portion of the integrated system. Some assays require additional temperature restrictions per the IFU reference appendix a: temperature sensitive assays.

Affected products

A. UniCel DxC 600i Synchron Access Clinical Systems

Lot or serial number

1074/800983/6941
1077/800986/6950
1135/801045/7152
1136/801046/7167
6384

Model or catalog number

4767

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES

B. UniCel DxC 600 Access Immunoassay System with Dual Gantry (Licence #75053, Class 2)

Lot or serial number

901183

Model or catalog number

A71461

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES

C. UniCel DxC 600 Access Immunoassay System with Dual Gantry (Licence #77901, Class 3)

Lot or serial number

901156

Model or catalog number

A71461

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES