Events

Recall of Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.

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
    27164
  • Event Risk Class
    Class 2
  • Event Number
    Z-0028-04
  • Event Initiated Date
    2003-09-02
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29333
  • 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
    unknown device name - Product Code LNN
  • Reason
    Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
  • Action
    Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers. An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.

Device

Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, ce...
  • Model / Serial
    All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.
  • Distribution
    United States, Canada and Germany
  • Product Description
    Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Road, Indianapolis IN 46250-0457
  • Source
    USFDA