Events

Rappel de Device Recall SpermMar Test

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 Vitrolife 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
    70131
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1448-2015
  • Date de mise en oeuvre de l'événement
    2014-12-22
  • Date de publication de l'événement
    2015-04-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132286
  • 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
    Reagent, immunoassay, igg - Product Code KTO
  • Cause
    The firm is recalling three batches (fp14a09, fp14a10, fp14a11) of spermmar iga test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.
  • Action
    FertiPro sent an Urgent: Medical Device Recall letter dated December 22, 2014, 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 check if they have stock of the concerned lots and provide a confirmation that they have destroyed the affected products. Distributors were asked to inform their customers and instruct them to do the same. For further questions you may call (858) 824-0888.

Device

Device Recall SpermMar Test
  • Modèle / numéro de série
    Manufacturer's Product Number/Catalog Number: SPMA_S  Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the state of : OR., and Internationally to Argentina.
  • Description du dispositif
    SpermMar Test || 0.7ml Beads Particles || Label on bottle: || SpermMar Test IgA || 0.7ml Beads/Particles-50 Tests || IND REF SPMA_S || LOT Expiration || DO NOT FREEZE/NE PAS CONGELER || FertiPro N.V. || Label on box: || SpermMar || Test || IGA || 50 Determination || Test Kit || CONTENTS || 1 vial SpermMar Latex Particles 0.7 ml || REF SPMA_S || FertiPro || FertiPro N.V. || Label on box: || SpermMar || Test || IgA || 50 Determination Test Kit || Contents: 1 vial SpermMar latex particles, 0.7ml || FertiPro N.V. || For In Vitro Diagnostic || Use || SpermMar IqA Test || Manufacturer's Product Number/Catalog Number: SPMA_S || Lot/Serial Number Expiration Date || FP14A09 02/29/2016 || FP14A10 04/30/2016 || FP14A11 04/30/2016 || Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
  • Manufacturer
    Vitrolife Inc

Manufacturer

Vitrolife Inc
  • Adresse du fabricant
    Vitrolife Inc, 6835 Flanders Dr Ste 500, San Diego CA 92121-3927
  • Société-mère du fabricant (2017)
    Vitrolife AB
  • Source
    USFDA