Events

Rappel de Phosphorus Reagent

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Abbott Laboratories, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66047
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0020-2014
  • Date de mise en oeuvre de l'événement
    2013-08-12
  • Date de publication de l'événement
    2013-10-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121322
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
  • Cause
    Reagent lots 64736un12, 03991un13, 51611un13, 74805un12, and 03992un13 have incorrect expiration dates assigned by supplier.
  • Action
    The firm, Abbott Laboratories, sent a "PRODUCT CORRECTION" letter dated August 12, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to update existing inventory and manually track the implanted lots with the corrected expiration dates listed in the letter; retain a copy of letter and if you have forwarded any of the lots listed to another laboratory, provide a copy of the letter to them. If you or any of your healthcare providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (422-2688). Customers outside the U.S., please contact your local area customer service.

Device

Phosphorus Reagent
  • Modèle / numéro de série
    For List Number: 7D71-22, Lot Numbers 64736UN12 (Exp Date on Label is 14 JAN 2014), 03991UN13 (Exp Date on Label is 01 APR 2014), and 51611UN13 (Exp Date on Label is 13 JUL 2014). For List Number: 7D71-31, Lot Numbers 74805UN12 (Exp Date on Label is 14 JAN 2014) and 03992UN13 (Exp Date on Label is 01 APR 2014).
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Austria, Australia, Azerbaijan, Bangladesh, Bahamas, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Burkina, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania ,Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, United Arab Emirates, United Kingdom, Uruguay and Vietnam.
  • Description du dispositif
    Clinical Chemistry Phosphorus Reagent || The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Adresse du fabricant
    Abbott Laboratories, Inc, 1921 Hurd Dr, Irving TX 75038-4313
  • 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