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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These antibodies and probes when used in combination with specified lots of the bond polymer refine detection and novolink polymer detection system may not provide adequate staining when used according to the instructions for use. if the products are used according to their instructions for use with appropriate positive controls the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and in a worst-case scenario could cause a delay in the diagnosis or classification of a neoplasm.
Model Catalog: PA0210 (Lot serial: all lots); Model Catalog: PB0645 (Lot serial: all lots); Model Catalog: PB0669 (Lot serial: all lots); Model Catalog: PB0785 (Lot serial: all lots); Model Catalog: PA0552 (Lot serial: all lots); Model Catalog: PB0614 (Lot serial: all lots); Model Catalog: PB0809 (Lot serial: all lots); Model Catalog: PB0589 (Lot serial: all lots); Model Catalog: NCL-L-AMACR (Lot serial: all lots)
제품 설명
BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMU1)