FDA recall Z-1354-2019

Abbott Ireland Diagnostics Division · Class II · device

Product

Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.

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.

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, S

Key facts

Status
Terminated
Initiation date
2019-02-05
Report date
2019-05-22
Termination date
2020-08-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Co. Longford, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1354-2019