Events

Recall of Device Recall Roche/Hitachi Modular P800 Module GMMI clinical chemistry analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    47371
  • Event Risk Class
    Class 2
  • Event Number
    Z-0867-2008
  • Event Initiated Date
    2008-03-21
  • Event Date Posted
    2008-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69516
  • Notes / Alerts
    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.
  • Extra notes in the data
    Chemistry analyzer - Product Code JJE
  • Reason
    Possible mismatch between patient and result.
  • Action
    Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.

Device

Device Recall Roche/Hitachi Modular P800 Module GMMI clinical chemistry analyzer
  • Model / Serial
    All units with software version 08-02.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina.
  • Product Description
    Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog number 04998669001. || Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. || Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
  • Source
    USFDA