Device 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.
Z-1353-2019
Product summary
- Event
- Event 82129
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,724
- Official record key
device-enforcement:Z-1353-2019
Official wording
Reason: Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Code information: List Number 7K72-20 - ALL LOTS, List Number 7K72-25 - ALL LOTS, and List number 7K72-35 - ALL LOTS.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.