Events

Rappel de Strep A Twist Rapid Test Cassette

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 Alere San Diego.

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
    60959
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1075-2012
  • Date de mise en oeuvre de l'événement
    2011-09-01
  • Date de publication de l'événement
    2012-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106889
  • 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
    Antigens, all groups, streptococcus spp. - Product Code GTY
  • Cause
    Alere san diego is expanding the scope of the voluntary recall of the strep a rapid test cassette and twist devices from the single lot that was recalled in january 12, 2011 to all lots of product that were on the market within the expiry period.
  • Action
    The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 1, 2011 to its customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to retain the recall letter for their records as documentation that they have received the recall information. Customers were instructed to follow the directions and return the attached Verification Form. Customers were instructed to use the table in the Verification Form to document all inventory at any of their inventory locations. Customers may use multiple forms to document all sites, products, and lots. Alere will issue credit against PO#ASD811STA for any unused portion of the product based on completion and return of the attached Verification Form. Customers with any technical questions about the information contained in the notification were instructed to contact Alere by phone (877) 866-5309, fax (877) 866-9304 or email: ca2services@Alere.com.

Device

Strep A Twist Rapid Test Cassette
  • Modèle / numéro de série
    All lots of Twist Devices product manufactured since August 2009.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of : Austria, Canada, Cyprus, Denmark, Finland, Germany, Greece, Hungary, Iceland, Italy, Poland, Portugal, Romania, Slovenia, Spain, Switzerland, and United Kingdom.
  • Description du dispositif
    Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. || Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist, PSS (5005); Medi-Lab Performance Strep A Test-Twist, McKesson (32-502T); MooreBrand Strep A Twist Cassette, Moore (82793); and SP Strep A Rapid Twist Cassette Test, Cardinal Health (B1077-29). || Type of Packaging (ie. box, plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50), the kits also include: disposable extraction test tubes, dropper tips, sterile swabs, 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite, 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid, 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3, 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box. || The Strep A Rapid Test Cassette and Twist devices are qualitative, lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab, providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.
  • Manufacturer
    Alere San Diego

Manufacturer

Alere San Diego
  • Adresse du fabricant
    Alere San Diego, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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