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