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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All the advia centaur xpt system software versions v1.0.1 (bundle 1.0.912 smn 10819704) v1.0.2 (bundle 1.0.1086 smn 11219806) v1.0.3 (bundle 1.0.1108 smn 11220781 11219656) v1.1 (bundle 1.1.243 smn 11221979 11222064) and v1.2 (bundle: 1.2.223.0 smn: 11222258 11223813)) may have the following issues which could affect the operation and workflow of the system: 1. system status unknown: the system may display an "unknown status" if a software error occurs due to: reagent barcode processing missing wash packs for mitigations processing of the ahavm assay during the daily cleaning or rinse operation software processing errors. 2. las communication: tubes received from the las may not be processed if the following conditions occur: - if the las is setup using custom test names in software v1.2 the reagent status is not sent to the las. the las may not route tubes to the system for processing if the reagent status is not known. - due to an internal system timing error samples may stop processing from the las if there is only one tube in the las queue and it is in the process of being indexed out just as another tube is being added. -3. qc profiles: if a new test is added to an existing qc profile the new test is not added into all levels of the qc material that exist in the qc profile the display will not show all control levels of the new test. therefore all controls may not be run for a new test. -4. 'no primary' error: a 'no primary' error is generated and tests are aborted under the following scenarios: - if any bulk consumable container is removed while a test already has a no primary error all tests for that tube will be flagged with a no primary flag. the tests will need to be re-ordered. - if an "immediate unload" of a primary reagent pack is requested by the user and the user then requests a "cancel unload" of the same pack. when the pack is depleted any tests scheduled for the reagent pack will be aborted and will need to be re-ordered. - if an auto-repeat is triggered and requires an auto-dilution an error in the calculation of the reagent volume required for the dilution may determine that there is insufficient reagent volume in any of the remaining onboard packs. -5. lis specification: the software does not operate according to the published lis specification. the following are corrections to the specification: - the order record does not follow the specification. the '^' symbol is not transmitted between the rack number and the position number under the following conditions: - 'send rack ids with results' is enabled in lis configuration.- the qc order has rack & position. - the qc sample is loaded using automation track or loaded on a rackid whose rack number is less than 1000 (ex: '1a' '20b' 999a'). - the rack id and position number in the query record are always sent to the lis regardless of which mode is being used on the system.