Events

Rappel de Device Recall SP Brand Strep A 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 Biosite Inc Dba Innovacon 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
    57715
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1395-2011
  • Date de mise en oeuvre de l'événement
    2011-01-12
  • Date de publication de l'événement
    2011-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97073
  • 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
    The recall was initiated after the investigation of customer-reported complaints, testing of market retention and returned product, it was determined that this lot of product has demonstrated an elevated incidence of non-specific binding, potentially causing false positive results. a false positive test result could lead to the administration of antibiotics that are unnecessary. this exposes the.
  • Action
    The firm, Alere San Diego, sent a "URGENT MEDICAL DEVICE RECALL" letter dated January 17, 2011. The letter described the product, problem and action to be taken by customers. The customers were instructed to: (1) Immediately discontinue use of the affected lot (if applicable) and inventory remaining full or partial kits at their site (if applicable); (2) Destroy any remaining inventory of this lot and document destruction per their site requirements (if applicable); (3) Complete and FAX the enclosed Verification Form within 10 days to confirm their receipt of this notice and to receive replacement of their remaining inventory of this lot (if applicable). The customers were ask to please return the form even if they have no remaining inventory or do not have any involved product in order to confirm receipt of this notification; and (4) to please ensure that all users of the device have received a copy of this Urgent Medical Device Recall. Customers with questions about the information contained in the notice were instructed to contact Technical Services at 888-246.7483, option 2 or by e-mail attechservices@alere.com.

Device

Device Recall SP Brand Strep A Cassette
  • Modèle / numéro de série
    Lot #: STA0010037
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution
  • Description du dispositif
    SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 || The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay 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
    Biosite Inc Dba Innovacon Inc.

Manufacturer

Biosite Inc Dba Innovacon Inc.
  • Adresse du fabricant
    Biosite Inc Dba Innovacon Inc., 9975 Summers Ridge Rd, San Diego CA 92121
  • 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