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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During a complaint investigation at the manufacturer (horiba abx sas) a shift in the target value of the abx pentra n control was detected for potassium-e values related to the abx pentra 400 only. clinical laboratories will observe the potassium n control result will be reported in the lower range of the n control target range. the original target value annex shipped with the abx pentra n control lot#: 1300801 identified the potassium target value as 4.00 mmol/l with a target range of 3.70 -4.30 mmol/l (equivalent to 15.6 mg/dl with a target range of 14.4 -16.8 mg/dl). horiba abx sas (the manufacturer) has reassigned the target value and range a nd updated the annex for this lot number to reflect a target value of 3.76 mmol/land a target range of 3.46 - 4.06 mmol/l (equivalent to 14.7 mg/dl with a target range of 13.5 - 15-.9 mg/dl) for potassium. this issue is only applicable to potassium-e values reported on the abx pentra 400 chemistry analyzer with the ise module only. no other analyzers or other analyte values are affected.