Events

Rappel de iCup DX

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 Ameditech Inc.

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
    72471
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0311-2016
  • Date de mise en oeuvre de l'événement
    2015-10-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141188
  • 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
    Enzyme immunoassay, benzodiazipine - Product Code JXM
  • Cause
    Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
  • Action
    Ameditech Inc. sent an Urgent Medical Device Recall Letter to al affected customers on October 20, 2015, to inform them that Ameditech is recalling affected lots of Ameditech's Drugs of Abuse Tests because they have shown reduced reactivity for up to three of the nineteen Benzodiazepine (BZO) compounds. The letter informs customers of the actions to be taken. Customers were instructed to complete and return the customer verification form to (858) 677-0243 or scan and email to amt.fieldaction@alere.com. For questions regarding this recall call 858-535-1968.

Device

iCup DX
  • Modèle / numéro de série
    141210 141425 141561 141870 141994 142126 143608 144152 144218 145067 150105 150167 151215 150976 141844 141929 142258 142314 143606 144511 145058 145059 150549 150867 150919 150920 151179 151190 151255 151338 151476 144377 150101 150285 150420 151161 151399 151696 144209 144463 150018 150107 150690 150883 141492 141519 141552 141726
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia.
  • Description du dispositif
    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; || iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; || iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; || iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; || iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; || iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; || iCup DX Drug Screen, Item No. I-DXA-1127-023 || These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. || ¿¿¿
  • Manufacturer
    Ameditech Inc

Manufacturer

Ameditech Inc
  • Adresse du fabricant
    Ameditech Inc, 9940 Mesa Rim Rd, San Diego CA 92121-2910
  • Source
    USFDA