Events

Rappel de Device Recall Roche Molecular Diagnostics Inc.

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 Roche Molecular Systems, 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
    67441
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1111-2014
  • Date de mise en oeuvre de l'événement
    2014-01-06
  • Date de publication de l'événement
    2014-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125455
  • 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
    real time Nucleic acid amplification system - Product Code OOI
  • Cause
    Numerous complaints have been filed that leaking cobas ¿ pcr media 4.3 ml ivd have been received from different lots of the cobas ¿ pcr urine kits, cobas ¿ pcr female swab kits, and cobas ¿ pcr media kits.
  • Action
    Roche Molecular Diagnostics Inc. sent an Urgent Medical Device Correction letter/Fax-back form dated January 6, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the test-skpecific Instruction For Use for handling of cobas PCR media 4.3 ml IVD. The use of protective equipment should be worn as indicated in the labeling. Inspection each tube and/or blister packet for evidence of leakage prior to use. If leakage of the cobas PCR media 4.3 mL IVD is observed, do not use the tubes. Discard the affected tubes per local guidelines and contact Roche Support Network Customer Support Center at 1-800-526-1247. Complete the attached fax form and fax it to 1-855-695-8564. File this Urgent Medical Device Correction (UMDC) for future reference. Customers with questions were instructed to call 1-800-526-1247. For questions regarding this recall call 908-253-7200.

Device

Device Recall Roche Molecular Diagnostics Inc.
  • Modèle / numéro de série
    K110923  cobas PCR Female Swab Sample Kit 05170516190 Lot S01487 and earlier  cobas PCR Urine Sample Kit 05170486190 Lot S01885 and earlier (except lot number S01884)  IVD: 48 kit batches US: 31 kit batches JPN-IVD:6 kit batches
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    cobas¿ PCR Urine Kit 100 PKT IVD || cobas¿ PCR Female Swab Kit 100 PKT IVD || cobas¿ PCR media 100T IVD || cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD || Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA || Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 || The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Adresse du fabricant
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA