Events

Recall of Alere hCG Combo Cassette (20/10 mIU/mL) KIt

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alere San Diego, 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
    65048
  • Event Risk Class
    Class 2
  • Event Number
    Z-1401-2013
  • Event Initiated Date
    2013-04-16
  • Event Date Posted
    2013-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117797
  • 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
    The firm initiated recall of alere" hcg combo cassette (20/10 miu/ml) kit pn 92215, lots hcg1110133 and hcg1110135, because an investigation has indicated a portion of these alere" hcg combo cassette (20/10 miu/ml) pn 92215 kit lots were incorrectly packaged with the alere" hcg cassette (20 miu/ml) pn 92210 product insert. the alere" hcg cassette (20 miu/ml) product insert contains information for.
  • Action
    Alere initiated this recall by sending recall notification letters, titled "URGENT MEDICAL DEVICE RECALL", dated April 16, 2013 via via fax, email or direct mail. The letter informed customers of the product recalled, reason for recall, customer required action, and contact information, "Alere Technical Services at 866-216-0094 or by e-mail at lateral.flow.support@alere.com.". A verification form was attached to the notification letter.

Device

Alere hCG Combo Cassette (20/10 mIU/mL) KIt
  • Model / Serial
    Lot/Unit Codes: hCG1110133 & hCG1110135  Part Number: 92215  Expiration date, or Expected shelf life: 9/30/13 & 10/31/13
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States Nationwide Distribution
  • Product Description
    Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. || Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • Manufacturer Address
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA