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
The primer in well 2/8/c is incorrect. as a result the presence of a b*38:07 allele would cause an assignment to b*38:06. these alleles are very rare occurring. the root cause investigations determined an error occurred during manufacturing- employees did not follow standard operating procedure and there is no verification check in the process. no adverse events or product complaints have been received.
Model Catalog: SSPR1-16 (Lot serial: Lot 002 batch 003); Model Catalog: SSPR1-16 (Lot serial: Lot 002 batch 002); Model Catalog: SSPR1-16 (Lot serial: Lot 002 batch 001)
제품 설명
Micro SSP Allele Specific HLA Class I DNA Typing tray-B*38/39