Events

Rappel de Device Recall Roche COBAS c 111 Analyzer

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 Diagnostics Corp..

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
    50170
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1009-2009
  • Date de mise en oeuvre de l'événement
    2008-11-17
  • Date de publication de l'événement
    2009-03-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74907
  • 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
    Chemistry Analyzer - Product Code JJE
  • Cause
    Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. without the glue, the cap can become loose or misaligned. the effect of these faulty valves is that they may not open or close properly which can disturb the fluid transportation within the ise module resulting in problems with ise calibration, con.
  • Action
    Consignees were notified via an Urgent Medical Device Correction letter dated 11/17/08 and instructed Roche will contact them to make an appointment to inspect their analyzers. A work around was provided, for interim use, in the letter. Customers were instructed to complete and fax back the "ISE Controls Request - Purchased from a Distributor." A no charge replacement product will be shipped to customers.

Device

Device Recall Roche COBAS c 111 Analyzer
  • Modèle / numéro de série
    Serial numbers: 50654, 50694, 50541, 50634, 50251, 50506, 50453, 50688, 50244, 50475, 50597, 50656, 50598, 50635, 50632, 50586, 50320, 50246, 50693, 50692, 50562, 50547, 50624, 50690, 50687, 50680, 50560, 50247, 50538, 50633, 50201, 50612, 50576, 50689, 50681, 50424, 50651, 50661, 50452, 50450, 50290, 50630, 50319, 50250, 50549, 50682, 50683, 50685, 50660, 50545, 50463, 50655, 50539, 50653, 50249, 50563, 50561, 50686, 50649, 50470, 50657, 50448, 50644, 50595, 50575, and 50679.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN. || Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Adresse du fabricant
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA