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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Within the current released versions of vitek 2 systems pc software (5.01 5.02 5.03 5.04 and 6.01) the breakpoints in the clsi parameter sets (which use the fda breakpoints) for ceftriaxone for b-hemolytic streptococci and viridans streptococci do not match the approved breakpoints from the current fda label.
Model Catalog: HP D530 CAT.#W0438R (Lot serial: All serial numbers); Model Catalog: HP D530 CAT.#W0438 (Lot serial: All serial numbers); Model Catalog: HP RP5800 CAT.# 413642 (Lot serial: All serial numbers); Model Catalog: HP RP5800 CAT.# 413642R (Lot serial: All serial numbers); Model Catalog: HP RP5800 CAT.# 413862 (Lot serial: All serial numbers); Model Catalog: HP RP5700 CAT.# W0452 (Lot serial: All serial numbers); Model Catalog: HP RP5700 CAT.# W0452R (Lot serial: All serial numbers); Model Catalog: HP DC7800 CAT.# W0449 (Lot serial: All serial numbers); Model Catalog: HP D530 CAT.#W0437 (Lot serial: All serial numbers); Model Catalog: HP DC7100 W0441R (Lot serial: All serial numbers); Model Catalog: HP DC7100 W0441 (Lot serial: All serial numbers); Model Catalog: HP DC7700 W0447R (Lot serial: All serial numbers); Model Catalog: HP DC7700 CAT.# W0447 (Lot serial: All serial numbers); Model Catalog: HP DC7800 CAT.# W0449R (Lot serial: All serial numbers); Model Catalog: HP D530 CAT.# W0438R (Lot serial