Events

Rappel de Device Recall Cyto Jar Fixative

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 Leica Biosystems Richmond 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
    61276
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1331-2012
  • Date de mise en oeuvre de l'événement
    2012-02-20
  • Date de publication de l'événement
    2012-03-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107702
  • 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
    Preservative, cytological - Product Code LEA
  • Cause
    Product was distributed with the incorrect lot number and expiration date. the lot number and expiration date should have been listed at 073013 and instead was noted as 073014 which is beyond the maximum expiration dating of 18 months for this product.
  • Action
    The firm, Leica Microsystems, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 17, 2012, via FedEx on February 20, 2012 to all affected customers. The letter describes the product, problem, and actions to be taken. A second letter was sent to the customers on February 29, 2012, clarifying that the incorrect lot number and expiration date was 073014, and should have been 073013. The customers were instructed to discontinue use of the product; return the product and complete and return the enclosed Acknowledgement Form via fax to 815-678-2216 within one week of receiving the notification. If you have any questions, contact the Regulatory Affairs Manager at toll free (800) 225-8867 or email: richmond@leica-microsystems.com.

Device

Device Recall Cyto Jar Fixative
  • Modèle / numéro de série
    item #3801825, reorder #01825, lot #073013
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: Michigan, Missouri and New York.
  • Description du dispositif
    Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cytologic specimens, 50 jars per case; for in vitro diagnostic use only; Leica Biosystems, 5205 Rt. 12, Richmond, IL 60071; Made in USA || The Cyto Jar is for the convenient collection, fixation and preservation of all cytologic specimens. The 120 mL clear, leakproof container is prefilled with 45 mL of preservative containing polyethylene glycol. It can be used for rinsing aspiration needles or bronchial brushes and for the direct collection of sputum specimens.
  • Manufacturer
    Leica Biosystems Richmond Inc.

Manufacturer

Leica Biosystems Richmond Inc.
  • Adresse du fabricant
    Leica Biosystems Richmond Inc., 5205 Route 12, Richmond IL 60071
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA