Z-1865-2016Class II

The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma

Name: Z-1865-2016 The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma
Creator: Abbott Laboratories
Published: 2016-03-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-03-24 / Terminated / root cause: design

FDA source

Abbott Laboratories began a recall of The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma on 2016-03-24. FDA classified it as Class II and gives the reason as "Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1865-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-24
Posted: 2016-05-31
Terminated: 2018-04-11
Recalling firm: Abbott Medical
Product: The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Product code: CHP Radioimmunoassay, Estradiol
Reason for recall: Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent a Product Correction letter dated 3/24/2016 to all affected consignees describing the nature of the recall as well as instructions to follow. The necessary actions included the following: Consignees are asked to review the letter with their Medical Director. Patients undergoing Fulvestrant therapy should not be tested with the ARCHITECT Estradiol assay. Complete the Customer Reply Form. If the consignee has forwarded the product listed to other laboratories, a copy of Product Correction letter should be provided to them. The customer is asked to retain the letter for their laboratory records. Customers with questions should contact either Customer Service at 1-877-4ABBOTT for the US; or, the local area customer service for outside of the US.
Quantity in commerce: 39,346 units
Distribution: Worldwide Distribution -- US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY; and, the countries of ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVI, BRAZIL, BRUNEI, BULGARIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALI, MAURITIUS, MEXICO, MONTENEGRO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TOGO, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM and ZIMBABWE.
Product codes and lots: Product List Number 07K7220 with Lot #: 55900UI01with expiration date of 04/23/2016, Lot #: 55908UI01 with expiration date of 04/29/2016, Lot #: 55941UI00 with expiration date of 04/23/2016, Lot #: 57929UI00 with expiration date of 07/16/2016, Lot #: 57931UI01 with expiration date of 07/27/2016, Lot #: 60105UI00 with expiration date of 10/02/2016 and Lot #: 61106UI00 with expiration date of 11/27/2016. Product List Number 07K7225 - Lot #: 55900UI00 with expiration date of 04/23/2016, Lot #: 55908UI00 with expiration date of 04/29/2016, Lot #: 57929UI01 with expiration date of 07/16/2016, Lot #: 57931UI00 with expiration date of 08/27/2016, Lot #: 60105UI01 with expiration date of 02/10/2016, Lot #: 61106UI01 with expiration date of 11/27/2016 and Lot #: 62263UI00 with expiration date of 11/27/2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1865-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1865-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)