Home / Recalls / Abbott Ireland Diagnostics Division / Z-1354-2019

Z-1354-2019 Class II Terminated

Recalled by Abbott Ireland Diagnostics Division — Co. Longford

FDA device recall Z-1354-2019 was initiated by Abbott Ireland Diagnostics Division on February 5, 2019 and is designated Class II. 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. The recall status is terminated (terminated August 21, 2020). Affected quantity: 64,618.

Recall Details

Product Type: Devices
Report Date: May 22, 2019
Initiation Date: February 5, 2019
Termination Date: August 21, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 64,618

Product Description

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 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.

Code Information

List Number 07P5020 - ALL LOTS and List Number 07P5030 - ALL LOTS.

Other recalls by Abbott Ireland Diagnostics Division

Z-1353-2019 Class II — Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol (February 5, 2019)
Z-0666-2019 Class II — Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 (November 21, 2018)
Z-0668-2019 Class II — Alinity i Progesterone Reagent Kit, List Number 08P3620 (November 21, 2018)
Z-0664-2019 Class II — Alinity i TSH Reagent Kit, List Number 07P4830 (November 21, 2018)
Z-0665-2019 Class II — Alinity i Free T4 Reagent Kit, List Number 07P7030 (November 21, 2018)
Z-0667-2019 Class II — Alinity i Estradiol Reagent Kit, List Number 07P5020 (November 21, 2018)
Z-0669-2019 Class II — Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 (November 21, 2018)
Z-2208-2019 Class II — Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin a (November 21, 2018)
Z-0799-2019 Class II — ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platfo (October 12, 2018)
Z-0798-2019 Class II — ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platfor (October 12, 2018)