Health product recall

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

  1. COULTER EPICS SERIES FLOW CYTOMETER SYSTEM - EPICS XL ANALYZER
  2. EPICS XL/MCL ANALYZER
  3. CYTOMICS FC 500 MPL (FLOW CYTOMETER) - INSTRUMENT
  4. 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

  1. 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