# FDA recall Z-1353-2019

> **Abbott Ireland Diagnostics Division** · Class II · device recall initiated 2019-02-05.

## 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.

## 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

- **Recall number:** Z-1353-2019
- **Recalling firm:** Abbott Ireland Diagnostics Division
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1353-2019

## Citation

> AI Analytics. FDA recall Z-1353-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1353-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*