Events

Recall of iCup DX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ameditech Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72471
  • Event Risk Class
    Class 2
  • Event Number
    Z-0311-2016
  • Event Initiated Date
    2015-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141188
  • Notes / Alerts
    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.
  • Extra notes in the data
    Enzyme immunoassay, benzodiazipine - Product Code JXM
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia.
  • Product Description
    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
  • Manufacturer Address
    Ameditech Inc, 9940 Mesa Rim Rd, San Diego CA 92121-2910
  • Source
    USFDA