Events

Rappel de Device Recall Sm ELISA Test System

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 Zeus Scientific 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
    49438
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1089-2009
  • Date de mise en oeuvre de l'événement
    2008-08-19
  • Date de publication de l'événement
    2009-03-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-04-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73329
  • 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
    Antinuclear Antibody Immunological Test System - Product Code LJM
  • Cause
    The calibrator value is printed incorrectly on the sm elisa test system, lot # 08041819. the calibrator value (cv) printed on the label is 102; the correct cv should read 266.
  • Action
    Urgent Recall Notice letters were sent out by Federal Express night mail on August 19, 2008 to all direct account. Wampole (Inverness) will notify their customers in a separate letter. Recall letters explained the reason for the recall and that the product does meet the company's criteria when it is used qualitatively to interpret index values or OD rations as outlined in the kit package insert. Customers are advised in the letter that the Calibrator Value of 102 is incorrect and that it should be 266. Instructions to correctly express the specimen results using specimen and calibrator OD values semi-qualitatively as Unit Values and the Calibrator Value (CV) or 266 are included. Letters also state that results for all patients using the incorrect CV of 102 should be recalculated using the correct CV of 266. All letters included a fax back form indicating that they have received the recall notification, have notified customers to correct the CV value for the Semi-Quantitative Conversion and have notified customers that have received the kit to correct the Semi-Quantitative Conversion of Optical Density to AAU/mL for the affected lot number of the Sm ELISA Test System.

Device

Device Recall Sm ELISA Test System
  • Modèle / numéro de série
    Lot number 08041819, Exp. 11/2009;, Lot number 08041811, Exp. 11/2009 (Inverness Medical - Wampole)
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Sm ELISA Test System || Product number 2Z2831G and Product number 43270CE || Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. || Manufactured by Zeus Scientific, Raritan, NJ 08869-0038. || Also manufactured for Wampole Laboratories, Princeton, NJ 08540 || Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use.
  • Manufacturer
    Zeus Scientific Inc

Manufacturer

Zeus Scientific Inc
  • Adresse du fabricant
    Zeus Scientific Inc, 200 Evans Way, Somerville NJ 08876-3767
  • Source
    USFDA