Events

Recall of Device Recall ARCHITECT DHEAS Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Gmbh & Co. KG.

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
    79482
  • Event Risk Class
    Class 2
  • Event Number
    Z-1629-2018
  • Event Initiated Date
    2017-12-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162437
  • 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
    Radioimmunoassay, dehydroepiandrosterone (free and sulfate) - Product Code JKC
  • Reason
    Falsely elevated results may be obtained when using the architect dhea-s assay with samples from infants up to 60 days old.
  • Action
    Customers were notified via letter on about 12/14/2017. Instructions included to immediately discontinue use of the ARCHITECH DHEA-S assay with samples form infants up to 60 days old, to immediately discontinue use of the ARCHITECH DHEA-S reagent insert Expected Values representative data for children up to 10 years old, to review the letter with the Medial Director and follow the laboratory protocol regarding the need for reviewing previously reported patient results, to forward the Product Correction letter to customers if the product was further distributed, and to complete and return the Customer Reply Form. Questions from U.S. customers can be directed to Customer Service at 1-877-4ABBOTT (available 24 hours per day, 7 days a week) and customers outside the U.S. should contact their local area Customer Service.

Device

Device Recall ARCHITECT DHEAS Reagent
  • Model / Serial
    List No. 8K2-20 with the following Lot No., Exp. Date, UDI:  a. Lot No. 01316K000, Exp. Date 04FEB2018, UDI (01) 00380740017446 (17) 180204 (10) 01316K000 (240) 8K2720;  b. Lot No. 01217A000, Exp. Date 13APR2018, UDI (01) 00380740017446 (17) 180413 (10) 01217A000 (240) 8K2720;  c. Lot No. 02217D000, Exp. Date 24JUN2018, UDI (01) 00380740017446 (17) 180624 (10) 02217D000 (240) 8K2720;  d. Lot No. 04117H000, Exp. Date 25NOV2018, UDI (01) 00380740017446 (17) 181125 (10) 04117H000 (240) 8K2720;   List No. 8K27-25 with the following Lot No., Exp. Date, UDI:  a. Lot No. 01216K000, Exp. Date 04FEB2018, UDI (01) 00380740017453 (17) 180204 (10) 01216K000 (240) 8K2725;  b. Lot No. 01117A000, Exp. Date 13APR2018, UDI (01) 00380740017453 (17) 180413 (10) 01117A000 (240) 8K2725;  c. Lot No. 02217C000, Exp. Date 17JUN2018, UDI (01) 00380740017453 (17) 180617 (10) 02217C000 (240) 8K2725;  d. Lot No. 02317D000, Exp. Date 24JUN2018, UDI (01) 00380740017453 (17) 180624 (10) 02317D000 (240) 8K2725;  e. Lot No. 02417D000, Exp. Date 24JUN2018, UDI (01) 00380740017453 (17) 180624 (10) 02417D000 (240) 8K2725;  f. Lot No. 00517F000, Exp. Date 02SEP2018, UDI (01) 00380740017453 (17) 180902 (10) 00517F000 (240) 8K2725;  g. Lot No. 02817H000, Exp. Date 21OCT2018, UDI (01) 00380740017453 (17) 181021 (10) 02817H000 (240) 8K2725
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VT, WA, WY. Distributed internationally to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Egypt, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mexico, Morocco, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Tajikistan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, Uganda, United Kingdom, Uruguay .
  • Product Description
    ARCHITECT DHEA-S Reagent || Product Usage: || It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
  • Manufacturer
    Abbott Gmbh & Co. KG

Manufacturer

Abbott Gmbh & Co. KG
  • Manufacturer Address
    Abbott Gmbh & Co. KG, Max-Planck-Ring 2, 65205, Wiesbaden Germany
  • 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