Events

Rappel de Device Recall ARCHITECT Prolactin MasterCheck

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.

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
    38439
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1222-2007
  • Date de mise en oeuvre de l'événement
    2007-07-06
  • Date de publication de l'événement
    2007-09-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-05-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53667
  • 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
    in vitro diagnostic control - Product Code JJX
  • Cause
    The architect prolactin masterchecks may not be stable at the recommended storage conditions of 2 to 8 degrees c through the expiration dating (15 months). the masterchecks may exceed the suggested tolerance limits listed in the reportable range/calibration verification section in appendix b of the architect isystem operations manual.
  • Action
    Abbott sent a Product Correction letter dated 7/6/07, to all customers who received the affected product lot, informing them that the ARCHITECT Prolactin MasterChecks may not be stable at the recommended storage condition of 2 to 8 degrees Celsius (C) through expiration dating (15 months). Labeling is being permanently updated to indicate that ARCHITECT Prolactin MasterChecks are to be stored frozen until first use. After thawing, ARCHITECT Prolactin MasterChecks can be stored unopened at 2-8 degrees C for thirty days or until expiration which ever occurs first. All future shipments will contain updated storage and handling conditions of the ARCHITECT Prolactin MasterCheck. They were requested to check their inventory to see if they have any remaining inventory of lot number 82900M. If they know the date the lot was received or the date it was thawed, they may continue to use the ARCHITECT Prolactin MasterChecks if it has been stored at 2 to 8 degrees C unopened for less than 30 days. If the material has been stored at 2 to 8 degrees C for greater than 30 days or they do not know the number of days it has been thawed, they were instructed to discard the material. Reimbursement for discarded kits will be provided based on information provided in the Customer Reply form. Until labeling is updated, it will be necessary to use an alternate material for verification of sensitivity, calibration linearity, and the reportable range of the ARCHITECT Prolactin assay. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits, and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. The accounts were requested to complete and fax back the customer reply form, acknowledging the receipt and understanding of the correction letter. Customers outside of the U.S., were requested to contact their local customer support representative.

Device

Device Recall ARCHITECT Prolactin MasterCheck
  • Modèle / numéro de série
    list 6C27-05, lot 82900M
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada.
  • Description du dispositif
    ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers; Abbott Laboratories, Abbott Park, IL 60064, list 6C27-05
  • Manufacturer
    Abbott Laboratories

Manufacturer

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