Events

Recall of Device Recall TestPack Plus hCG Combo with On Board Controls (OBC)

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

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
    31466
  • Event Risk Class
    Class 3
  • Event Number
    Z-1392-05
  • Event Initiated Date
    2005-03-16
  • Event Date Posted
    2005-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37946
  • 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
    False positive results may be obtained with the identified lots of list 7b34-16 when using a negative patient sample or a negative control.
  • Action
    Abbott notified their affiliates in all four countries via e-mail on 3/16/05. Each Abbott international country organization is responsible for translating the customer letter, contacting customers and determining the method of effectiveness checks based on their country requirements. The recall letters inform the accounts of the false positve results, and were requested to destroy any remaining inventory of the affected lots.

Device

Device Recall TestPack Plus hCG Combo with On Board Controls (OBC)
  • Model / Serial
    list number 7B34-16, lot numbers 16006M200 and 19199M300
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Germany, Hong Kong and Australia
  • Product Description
    ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

Abbott Laboratories MPG
  • Manufacturer Address
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA