Events

Rappel de Device Recall VITROS Immunodiagnostic Products Estradiol Reagent Pack

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 ORTHO-CLINICAL DIAGNOSTICS.

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
    74764
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2352-2016
  • Date de mise en oeuvre de l'événement
    2016-07-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148401
  • 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
    Radioimmunoassay, estradiol - Product Code CHP
  • Cause
    Ortho clinical diagnostics has issued a recall of their vitros immunodiagnostics estradiol reagent assay. the firm was made aware of a potential cross-reactivity between the drug fulvestrant and thevitros immunodiagnostic estradiol reagent assay. the firm conducted an internal investigation and was able to confirm biased positive (ranging from 1303-4046%) on estradiol results, obtained from postmenopausal females taking fulvestrant.
  • Action
    On 7/14/2016, URGENT PRODUCT CORRECTION NOTIFICATION Customer Letter (Ref. CL2016-141, dated 7/14/2016) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received product since 6/1/2015 to inform them that Fulvestrant is an interferent of the Estradiol Reagent Pack and causes positively biased results. Discuss any concerns you may have regarding previously reported estradiol results with your Laboratory Medical Director to determine the appropriate course of action. The results from this or any other diagnostic test should be used and interpreted only within the context of the overall clinical picture. For questions, contact Customer Technical Services at 1-800-421-3311. Foreign affiliates were informed of the issue via e-mail on 7/14/2016 and instructed to notify their consignees of the issue.

Device

Device Recall VITROS Immunodiagnostic Products Estradiol Reagent Pack
  • Modèle / numéro de série
    Lot numbers: 1470 (expiry date 02-Aug-16); 1480 (expiry date 05-Aug-16), 1490 (expiry date 10-Oct-16), 1500 (expiry date 10-Oct-16), 1510 (expiry date 01-Nov-16), 1528 (expiry date 01-Nov-16) 1538 (expiry date 14-Mar-17), 1548 (expiry date 09-Mar-17), 1558 (expiry date 09-Mar-17) and 1568 (expiry date 29-Mar-17)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Puerto Rico, and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, Venezuela.
  • Description du dispositif
    VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS
  • Adresse du fabricant
    ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
  • Société-mère du fabricant (2017)
    The Carlyle Group LP
  • Source
    USFDA