Class 2 Device Recall ARCHITECT Estradiol Reagent Kit

• Date Initiated by Firm: February 05, 2019
• Create Date: May 16, 2019
• Recall Status: Terminated on August 21, 2020
• Recall Number: Z-1353-2019
• Recall Event ID: 82129
• Product Classification: Radioimmunoassay, estradiol - Product Code CHP
• Product: Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
• Code Information: List Number 7K72-20 - ALL LOTS, List Number 7K72-25 - ALL LOTS, and List number 7K72-35 - ALL LOTS.
• Recalling Firm/ Manufacturer: Abbott Ireland Diagnostics Division; Lisnamuck; Co. Longford Ireland
• Manufacturer Reason for Recall: Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
• FDA Determined Cause: Under Investigation by firm
• Action: On February 5, 2019, the firm sent Product Correction Urgent - Immediate Action Required letters to all their consignees which alerted them to the current issue. We recommend that you follow the necessary actions below: Patients treated with Mifepristone should not be tested with the ARCHITECT or Alinity i Estradiol assay for up to two weeks based on information available regarding Mifepristones bioavailability. - Please review this letter with your Medical Director. - If you have forwarded the products listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. - Complete the customer reply form. - Please retain this letter for your laboratory records. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
• Quantity in Commerce: 2,724
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR. AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, KS, MT, NC, ND, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, AND PUERTO RICO, and countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovi, Brazil, Brunei, Botswana, Canada, Chile, China, Columbia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland,Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Mauritius, Mexico, Moldova, Montenegro, Morocco, Mozambique, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland,Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turks, UAE, Uganda, United Kingdom, and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.