Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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원인
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.
Model Catalog: 626552 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 6604988 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 626554 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 626551 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 6605464 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 6605628 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 626553 (Lot serial: ALL SOFTWARE VERSIONS)
제품 설명
EPICS XL/MCL ANALYZER;CYTOMICS FC 500 MPL (FLOW CYTOMETER) - INSTRUMENT;COULTER EPICS SERIES FLOW CYTOMETER SYSTEM - EPICS XL ANALYZER;CYTOMICS FC 500 FLOW CYTOMETER