Events

Recall of Device Recall Roche Acetaminophen Roche/Hitachi

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

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
    57513
  • Event Risk Class
    Class 2
  • Event Number
    Z-1679-2011
  • Event Initiated Date
    2010-12-07
  • Event Date Posted
    2011-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96434
  • 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
    Colorimetry, acetaminophen - Product Code LDP
  • Reason
    The current product labeling for acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. additional testing has been performed to quantify the impact of these interferences at different concentrations and different levels of acetaminophen. low serum concentrations of acetaminophen were included in the study.
  • Action
    The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 07, 2010 to its customers. The letter described the product, problem, and action to be taken. The customers were instructed to be aware that endogenous interferents (i.e., bilirubin, hemolysis, and/or lipemia) may produce a falsely elevated value for samples containing concentrations less than 50 ug/ml of acetaminophen; complete and return the attached UMDC Faxback Form for Acetaminophen Assay via fax to 1-817-868-5343, and file this letter for future reference. The firm ask the customers to please consult with the physician or pathologist at their facility to determine specific clinical implications for their patients. The firm is also updating the product labeling to include information regarding the interference of icteric, hemolytic or lipemic samples. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have any questions about the information contained in this Urgent Medical Device Correction (UMDC).

Device

Device Recall Roche Acetaminophen Roche/Hitachi
  • Model / Serial
    11021000, 11071000 and 11070900.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN. || For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA