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Abbott Laboratories recalls The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Recalled June 8, 2016 · FDA recall Z-1865-2016 · Abbott Laboratories
Hazard
Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant. · FDA Class II
Units
39,346 units
Sold at
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.
Description
Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
Product
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Manufacturer(s)
Abbott Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →