COULTER EPICS Flow Cytometers, Cytomics FC500 Flow Cytometer, Cytomics FC 500 MPL (Flow Cytometer) and EPICS XL/MCL Analyzer (2018-01-08)
- Starting date:
- January 8, 2018
- Posting date:
- January 16, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-65714
Affected products
- COULTER EPICS SERIES FLOW CYTOMETER SYSTEM - EPICS XL ANALYZER
- EPICS XL/MCL ANALYZER
- CYTOMICS FC 500 MPL (FLOW CYTOMETER) - INSTRUMENT
- CYTOMICS FC 500 FLOW CYTOMETER
Reason
As a result of customer complaints and subsequent internal investigations, Beckman Coulter has determined that an internal electronic component on the circuit "amplifier" boards in the Epics XL/XL MCL Flow Cytometry Systems may be affected by a manufacturing defect. Each Epics XL/XL MCL system contains up to seven (7) of the potentially affected amplifier boards. All instruments are potentially impacted.
Affected products
-
COULTER EPICS SERIES FLOW CYTOMETER SYSTEM - EPICS XL ANALYZER
Lot or serial number
All software versions.
Model or catalog number
- 626551
- 6605464
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. EPICS XL/MCL ANALYZER
Lot or serial number
All software versions.
Model or catalog number
626552
6604988
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. CYTOMICS FC 500 MPL (FLOW CYTOMETER) - INSTRUMENT
Lot or serial number
All software versions.
Model or catalog number
626554
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
D. CYTOMICS FC 500 FLOW CYTOMETER
Lot or serial number
All software versions.
Model or catalog number
626553
6605628
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES