Events

Recall of Device Recall Roche / Hitachi MODULAR Analyzer Systems

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

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
    78756
  • Event Risk Class
    Class 2
  • Event Number
    Z-0499-2018
  • Event Initiated Date
    2017-07-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160289
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    A software malfunction can occur on the cobas e 411 and elecsys 2010 analyzers in the sample& control data file which may lead to a potential data mismatch.
  • Action
    All consignees were notified by Urgent Medical Device Correction sent via UPS Ground (receipt required) on July 5, 2017. The customer is advised to perform the following actions: cobas e 411: Until the software update is available, use the workaround outlined in the Urgent Medical Device Correction (UMDC). Elecsys 2010: Use the workaround outlined in this Urgent Medical Device Correction (UMDC). Non-responding accounts will be defined as users for which confirmation of receipt of the Urgent Medical Device Correction (UMDC) cannot be obtained. These accounts will be monitored on an ongoing basis and follow-up attempts will be made accordingly. Workaround for customers: he customer is advised to perform the following actions: cobas e 411: Until the software update is available, use the workaround outlined in the Urgent Medical Device Correction (UMDC). Elecsys 2010: Use the workaround outlined in this Urgent Medical Device Correction (UMDC). For further questions, please call (317) 521-7259

Device

Device Recall Roche / Hitachi MODULAR Analyzer Systems
  • Model / Serial
    none
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 || Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
  • Manufacturer
    Roche Diagnostics Corporation

Manufacturer

Roche Diagnostics Corporation
  • Manufacturer Address
    Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA