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 constituent inhibin a was removed from mas omni-immune and mas omni-immune pro controls however the package insert was not updated to reflect removal. the affected lots ahould not be used as control material for monitoring inhibin a assays. no other analytes of the mas omni-immune and mas omni-immune pro controls are affected.
Model Catalog: OIM-202 (Lot serial: OIM15092); Model Catalog: OIM-101 (Lot serial: OIM15091); Model Catalog: OPRO-202 (Lot serial: OPRO15102); Model Catalog: OPRO-SP (Lot serial: OPR1510S); Model Catalog: OPRO-303 (Lot serial: OPRO15103); Model Catalog: OIM-303 (Lot serial: OIM15093); Model Catalog: OPRO-101 (Lot serial: OPRO15101); Model Catalog: OIM-SP (Lot serial: OIM1509S)
제품 설명
MAS OMNI IMMUNE LEVEL 2;MAS OMNI IMMUNE LEVEL 1;MAS OMNI IMMUNE PRO LEVEL 2;MAS OMNI IMMUNE PRO;MAS OMNI IMMUNE PRO LEVEL 3;MAS OMNI IMMUNE LEVEL 3;MAS OMNI IMMUNE PRO LEVEL 1;MAS OMNI IMMUNE