Events

Rappel de ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CONTROLS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par FISHER SCIENTIFIC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    45862
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-12-10
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CONTROLS
  • Modèle / numéro de série
    Model Catalog: A11A01653 (Lot serial: 1300801)
  • Description du dispositif
    ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CONTROLS
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC