Z-1354-2019Class II

Abbott Alinity i Estradiol Reagent Kit -

Name: Z-1354-2019 Abbott Alinity i Estradiol Reagent Kit -
Creator: Abbott Ireland Diagnostics Division
Published: 2019-02-05
License: https://open.fda.gov/license/

Abbott Ireland Diagnostics Division / initiated 2019-02-05 / Terminated

FDA source

Abbott Ireland Diagnostics Division began a recall of Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the... on 2019-02-05. FDA classified it as Class II and gives the reason as "Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1354-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-05
Posted: 2019-05-16
Terminated: 2020-08-21
Recalling firm: Abbott Ireland Diagnostics Division
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.
Product code: CHP Radioimmunoassay, Estradiol
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 root 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: 64,618
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.
Product codes and lots: List Number 07P5020 - ALL LOTS and List Number 07P5030 - ALL LOTS.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1354-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1353-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1354-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16

Product code CHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)