Devices

Device Recall Abbott Laboratories, Inc., ARCHITECT Estradiol assay

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    The ARCHITECT Estradiol Kit || Intended to measure estradiol, an estrogenic steroid, in plasma.
  • Manufacturer
    Abbott Laboratories
  • 1 Event

Fabricant

Abbott Laboratories
  • Adresse du fabricant
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA