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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The manufacturer gen-probe gti diagnostics has recently notified us that they have observed anomalous increases in the optical density (od) of the negative control used with certain lifecodes assays. as a precautionary measure the expiration date of the negative control used with certain assays has been shortened. kits not listed in this letter are either not affected by the change in expiry or the labeling represents the appropriate expiration date.
Model Catalog: PAKPLUS (Lot serial: MORE THEN 10 CONTACT MFR); Model Catalog: PAK12 (Lot serial: MORE THEN 10 CONTACT MFR); Model Catalog: PAK12-G (Lot serial: MORE THEN 10 CONTACT MFR)