Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
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Recalling Organisation: Abacus ALS Limited, 55b Richard Pearse Drive, Airport Oaks, Auckland 2022
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As part of post-market surveillance activities, the cryptococcal antigen lateral flow assay (crag lfa) were found to have reduced specificity (90% now versus 99% before).