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
Affinity biologicals has determined that there was an error in the dilution factors provided in the preparation of the calibration curve section of the ifu (instructions for use) provided with these products. the provided dilution factors were: 1/10 1/20 1/40 1/180 1/160. the correct dilution factors are: 1/10 1/20 1/40 1/80 1/160. this is a typographical error only the description and volumes listed in the table preparation of calibration curve dilutions are correct.
Model Catalog: FRDP120125 (Lot serial: 0005-12FDP); Model Catalog: FRDP120105 (Lot serial: 0004-12FDP); Model Catalog: FRDP120125 (Lot serial: 0004-12FDP); Model Catalog: FRDP120105 (Lot serial: 0005-12FDP); Model Catalog: FRDP070125 (Lot serial: 0006-7FDP); Model Catalog: FRDP070105 (Lot serial: 0006-7FDP); Model Catalog: FRDP070105 (Lot serial: 0004-7FDP); Model Catalog: FRDP070105 (Lot serial: 0005-7FDP); Model Catalog: FRDP070125 (Lot serial: 0004-7FDP); Model Catalog: FRDP070125 (Lot serial: 0005-7FDP); Model Catalog: FRDP050125 (Lot serial: 0006-5FDP); Model Catalog: FRDP050105 (Lot serial: 0006-5FDP); Model Catalog: FRDP050105 (Lot serial: 0004-5FDP); Model Catalog: FRDP050105 (Lot serial: 0005-5FDP); Model Catalog: FRDP050125 (Lot serial: 0004-5FDP); Model Catalog: FRDP050125 (Lot serial: 0005-5FDP); Model Catalog: FRDP110125 (Lot serial: 0005-11FDP); Model Catalog: FRDP090105 (Lot serial: 0004-9FDP); Model Catalog: FRDP090125 (Lot serial: 0004-9FDP); Model Catalog: FRDP110105 (Lot serial: 0005-11FDP
제품 설명
VISUDEP-F FROZEN FACTOR XII DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR VII DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR V DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR XI DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR IX DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR X DEFICIEN