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.
데이터 추가 비고
원인
When results of "---.-" are received from the sysmex uf-100 instrument and if the user set the driver configuration option "strip zeros from result" to "yes" all versions prior to v7.00.0006 and v8.00.0005 of the sysu100i driver convert the results to "0.00" in instrument manager. the sysmex uf-100 will send "--.-" when the test has a sample error. all five urinalysis tests performed (rbc wbc ec cast and bact) will be resulted as "0.00" in instrument manager. this could lead to misdiagnosis and mistreatment of a patient.
Model Catalog: 8.00.0003 (Lot serial: Not applicable); Model Catalog: 8.00.0002 (Lot serial: Not applicable); Model Catalog: 8.00.0004 (Lot serial: Not applicable); Model Catalog: 7.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0002 (Lot serial: Not applicable); Model Catalog: 7.00.0003 (Lot serial: Not applicable); Model Catalog: 7.00.0005 (Lot serial: Not applicable); Model Catalog: 8.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0004 (Lot serial: Not applicable)
제품 설명
Instrument Manager Software using the sysu100i driver that connects to the Sysmex UF-100 instrument