Events

Rappel de Device Recall Pointe Scientific G6PD Screening Controls

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 Pointe 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
    71988
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2487-2015
  • Date de mise en oeuvre de l'événement
    2015-05-19
  • Date de publication de l'événement
    2015-08-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139536
  • 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
    Glucose-6-phosphate dehydrogenase (erythrocytic), screening - Product Code JBF
  • Cause
    A reduction in the reconstituted stability has been identified. clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. for this reason we suggest discontinuing use of the control set.
  • Action
    The firm, POINTE SCIENTIFIC, issued a "TECHNICAL BULLETIN" on 5/19/2015, notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, and actions to be taken. The customers were instructed to: discontinue use of the control set and to incorporate this bulletin into your Quality Control files. The firm noted that this product has been placed on indefinite back-order and a replacement product is not currently available. For questions contact Pointe Scientific's Technical Service Department at 1-800-757-5313.

Device

Device Recall Pointe Scientific G6PD Screening Controls
  • Modèle / numéro de série
    Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia.
  • Description du dispositif
    Pointe Scientific G6PD Controls || Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). || Also sold as individual vials || Bottle: Clear glass vials || Cap: Rubber seal with colored aluminum seals || Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.
  • Manufacturer
    Pointe Scientific, Inc.

Manufacturer

Pointe Scientific, Inc.
  • Adresse du fabricant
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Société-mère du fabricant (2017)
    Medtest Holdings Inc
  • Source
    USFDA