Events

Rappel de ABX PENTRA Calcium CP Reagent, Model A11A01633

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Horiba Instruments, Inc dba Horiba Medical.

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
    66209
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2280-2013
  • Date de mise en oeuvre de l'événement
    2013-09-06
  • Date de publication de l'événement
    2013-09-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121755
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Cresolphthalein complexone, calcium - Product Code CIC
  • Cause
    Horiba medical is informing all pentra 200 and pentra 400 customers of a potential for reporting incorrect calcium results when using the abx pentra calcium cp reagent.
  • Action
    Horiba Medical sent an Urgent Safety Notice dated September 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer notification letter dated September 6, 2013 will be sent to all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent (Reference #: A11A01633) Lot#: 014664503. The recall letter informs the customers that the initial functional tests indicate that there is no interference identified with regards to the patient results. However, with time, there may be an increase in the quantity of precipitates and this could potentially interfere with the performance of this reagent. Customers are informed of the actions to be taken and to complete the customer response form within 10 days. Further questions please call (949) 453-0500 Ext. 208

Device

ABX PENTRA Calcium CP Reagent, Model A11A01633
  • Modèle / numéro de série
    Lot/Serial #(s): 014664503
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including the country of Canada.
  • Description du dispositif
    ABX PENTRA Calcium CP Reagent, Model # A11A01633 || Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical

Manufacturer

Horiba Instruments, Inc dba Horiba Medical
  • Adresse du fabricant
    Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
  • Société-mère du fabricant (2017)
    Horiba Ltd.
  • Source
    USFDA