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
This recall/product correction is related to a possible sample carry-over for some hia reagent across roche systems platforms (cobas c311/501/502/701/702 modular p and cobas integra 800).
Model Catalog: 03507190190 (Lot serial: all lots); Model Catalog: 03507432190 (Lot serial: all lots); Model Catalog: 05220718190 (Lot serial: all lots); Model Catalog: 11972855216 (Lot serial: all lots); Model Catalog: 05220726190 (Lot serial: all lots); Model Catalog: 20737771322 (Lot serial: all lots); Model Catalog: 05219205190 (Lot serial: all lots); Model Catalog: 03507343190 (Lot serial: all lots); Model Catalog: 20737755322 (Lot serial: all lots); Model Catalog: 04956923190 (Lot serial: all lots); Model Catalog: 04956885190 (Lot serial: all lots)
제품 설명
IGM-2 (TINA-QUANT IGM GEN.2) FOR USE ON COBAS C SYSTEMS ANALYZERS;IGG-2 (TINA-QUANT IGG GEN.2) FOR USE ON COBAS C SYSTEMS ANALYZERS;IGG-2 (TINA-QUANT IGG GEN.2) FOR USE ON C701 ANALYZER;HITACHI TINA-QUANT C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE ASSAY (C