Events

Recall of Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).

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
    29893
  • Event Risk Class
    Class 3
  • Event Number
    Z-1435-04
  • Event Initiated Date
    2004-08-20
  • Event Date Posted
    2004-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34738
  • 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
    Nadh Oxidation/Nad Reduction, Ast/Sgot - Product Code CIT
  • Reason
    Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.
  • Action
    Consignees were mailed recall notices dated 8/20/04 and were instructed to either reduce the initial reagent bottle volume prior to use, or to request replacement product.

Device

Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module;...
  • Model / Serial
    All lots expiring on or before 7/05.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA