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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Ortho clinical diagnostics (ortho) has initiated this recall due to customer complaints regarding an inability to obtain a valid calibration when using vitros syphilis tpa reagent packs lots 0514 and 0520. ortho's investigation confirmed that these lots of vitros syphilis tpa reagent packs met all quality assurance release specifications. however subsequent to release these lots exhibited a reduction in reaction signal for calibrator level 1. initial testing indicates that the unexpected signal decrease is related to a specific lot of raw material used in the manufacture of the product.