Events

Rappel de Device Recall MicroScan Pos Breakpoint Combo Panel Type 20

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 Beckman Coulter 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
    72779
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0561-2016
  • Date de mise en oeuvre de l'événement
    2015-12-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142201
  • 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
    Panels, test, susceptibility, antimicrobial - Product Code LTT
  • Cause
    Beckman coulter has confirmed falsely negative results for voges-proskauer (vp) (pale-pink/brown/colorless) with quality control (qc) american type culture collection (atcc) organism staphylococcus aureus atcc 29213 in a portion of affected lots of microscan pos combo and microscan pos breakpoint combo panels. the expected result is positive.
  • Action
    The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use and discard any remaining inventory of lots listed; return the attached form for product replacement; retain your inventory of the other lot numbers of the panel types, as they are not impacted by this issue; discuss content of the letter with your laboratory director/staff, retain the notification as part of your laboratory QS documentation; if you have forwarded any of the affected products to another laboratory provide them a copy of the letter, and complete and return the enclosed Response Form within 10 days via mail to: Beckman Coulter, Inc., 1584 Enterprise Blvd., West Sacramento, CA 95691, Attn: Quality Systems & Compliance or Fax: 916-374-2119 or email: MicrobiologyCustomersHCUS@beckman.com. Customers with questions are instructed to contact their Customer Support Representative at http://www.beckmancoulter.com or by phone at (800) 677-7226 in US and Canada.

Device

Device Recall MicroScan Pos Breakpoint Combo Panel Type 20
  • Modèle / numéro de série
    2016-04-30 Part No. B1017-202
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
  • Description du dispositif
    MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA