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
Related to customer complaint investigation a potential situation concerning dispenser issues with hematoxylin ii and horseradish peroxydase reagents where it was reported that these reagents dispensers could be leaking or sticking. this failure could result in a complete or partial dispense failure of a reagent critical to the staining reaction potentially leading to erroneous results.
Model Catalog: 760-099 (Lot serial: More than 10-contact manufact.); Model Catalog: 860-099 (Lot serial: More than 10-contact manufact.); Model Catalog: 790-2208 (Lot serial: More than 10-contact manufact.); Model Catalog: 605-100 (Lot serial: More than 10-contact manufact.); Model Catalog: 760-500 (Lot serial: More than 10-contact manufact.); Model Catalog: 800-098 (Lot serial: More than 10-contact manufact.); Model Catalog: 760-700 (Lot serial: More than 10-contact manufact.); Model Catalog: 760-091 (Lot serial: More than 10-contact manufact.)
제품 설명
OPTIVIEW AMPLIFICATION KIT;HEMATOXYLIN II;CINTEC PLUS CYTOLOGY KIT;ULTRAVIEW UNIVERSAL DAB DETECTION KIT;ULTRAVIEW SISH DNP DETECTION KIT;OPTIVIEW DAB IHC DETECTION KIT;IVIEW DAB DETECTION KIT