Events

Recall of Device Recall Signify hCG Serum/Urine 30 Test Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Applied Biotech 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
    35542
  • Event Risk Class
    Class 2
  • Event Number
    Z-1100-06
  • Event Initiated Date
    2006-05-05
  • Event Date Posted
    2006-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46365
  • 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
    Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
  • Reason
    Certain kits from the product lot may contain test devices which contain incorrect reaction strips. use of such devices may produce false negative results with patient samples at and above the limit of detection of the product.
  • Action
    Distribution records indicate that the above product lot was produced for sale to Abbott Laboratories and Abbott Laboratories received all of the product lot. A recall certified recall letter was mailed 05/08/06. Abbott was also instructed if they have further distributed any of the referenced product lot, please see that their accounts are contacted, advise them of the urgent notification, and instruct them to destroy any of the affected product lot.

Device

Device Recall Signify hCG Serum/Urine 30 Test Kit

Manufacturer

Applied Biotech Inc
  • Manufacturer Address
    Applied Biotech Inc, 10237 Flanders Ct, San Diego CA 92121-2901
  • Source
    USFDA