UniCel DxI 600 and 800 Access Immunoassay Systems (2018-12-03)
- Starting date:
- December 3, 2018
- Posting date:
- January 8, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68692
Affected products
- UniCel DxI 600 Access Immunoassay Systems
- UniCel DxI 800 Access Immunoassay Systems
- UniCel DxI 800 Access Immunoassay Systems
- UniCel DxI 600 Access Immunoassay Systems
Reason
Beckman Coulter has determined that Unicel DxI 600 and 800 system software versions 5.2, 5.3.0 and 5.3.1 contain a defect that has the potential to cause erroneous results when the instrument is operated while connected to an automation line.
Affected products
A. UniCel DxI 600 Access Immunoassay Systems
Lot or serial number
- 900777
- 901626
Model or catalog number
-
A71460
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES
B. UniCel DxI 800 Access Immunoassay Systems
Lot or serial number
- 605300
- 605301
- 605516
- 605636
Model or catalog number
- A71456
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES
C. UniCel DxI 800 Access Immunoassay Systems
Lot or serial number
- 605300
- 605301
- 605516
- 605636
Model or catalog number
- A71456
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES
D. UniCel DxI 600 Access Immunoassay Systems
Lot or serial number
- 900777
- 901626
Model or catalog number
- A71460
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES