Events

Recall of Device Recall NEFA Standard

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wako Chemicals USA, 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
    37921
  • Event Risk Class
    Class 3
  • Event Number
    Z-1071-2007
  • Event Initiated Date
    2007-03-30
  • Event Date Posted
    2007-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52241
  • 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
    in vitro diagnostic - Product Code JIT
  • Reason
    Diagnostic reagent for clinical laboratory testing was incorrectly labeled.
  • Action
    The recalling firm notified consignees by letter 03/30/07 and advised of labeling error. Consignees were advised that they could return the product for relabeling or affix correct label enclosed with the notification. Distributors were requested to forward notification to end users. The firm subsequently notified consignees on 04/26/07 by fax that product should be returned for label correction.

Device

Device Recall NEFA Standard
  • Model / Serial
    Lot TQ087, Exp 02/29/08
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Germany and Canada.
  • Product Description
    NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237***
  • Manufacturer
    Wako Chemicals USA, Inc.

Manufacturer

Wako Chemicals USA, Inc.
  • Manufacturer Address
    Wako Chemicals USA, Inc., 1600 Bellwood Rd, Richmond VA 23237-1326
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA