Device Recall Roche Molecular Diagnostics Inc.

Fabricant

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

Un dispositif médical avec un nom similaire

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  • 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
  • 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