Events

Recall of Device Recall SP hCG Cassette Rapid Test

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
    49026
  • Event Risk Class
    Class 3
  • Event Number
    Z-1344-2013
  • Event Initiated Date
    2013-01-21
  • Event Date Posted
    2013-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72543
  • 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
    Alere san diego inc. is recalling the cardinal health hcg cassette rapid test because some of them were incorrectly packaged into cardinal health hcg combo rapid test kit boxes. the kit box incorrectly indicates the product may be used for both urine and serum sample types.
  • Action
    The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 21, 2013 to all their customers. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of the product; immediately discard all units of the the product in accordance with your local regulations; share this information with your laboratory staff and retain this letter for your records; if you have forwarded the product to another laboratory, provide a copy of this letter to them and include the name, address and a contact for the laboratory on the enclosed Customer Verification Form; complete and return the Customer Verification Form within 10 days via fax to: Technical Service at 858-805-8457 or e-mail to responses.ts@alere.com. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at lateral.flow.support@alere.com.

Device

Device Recall SP hCG Cassette Rapid Test
  • Model / Serial
    Lot: hCG2080330
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, AK, AR, AZ, CA, CO, CT, DE, HI, IA, ID, IL, IN, FL, GA, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, UT, TN, TX, VA, WA, WI, WV AND WY.
  • Product Description
    Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) || The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
  • 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