—#145060

Product

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

FDA product code: CHP — Radioimmunoassay, Estradiol
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: 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.

Why it was recalled

Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-03-24
Terminated: 2018-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.