Events

Recall of Device Recall Wako Autokit Lp(a) Calibrator

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
    61084
  • Event Risk Class
    Class 3
  • Event Number
    Z-1377-2012
  • Event Initiated Date
    2012-01-30
  • Event Date Posted
    2012-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107371
  • 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
    Lipoprotein, low-density, antigen, antiserum, control - Product Code DFC
  • Reason
    In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
  • Action
    Wako Diagnostics notified its customers by telephone on January 26, 2012 and sent an Urgent Medical Device Recall letter dated January 30, 2012 to inform them of the product recall. The notifications identified the affected product, problem and actions to be taken. Consignees were requested to: 1) Complete and sign the attached Return Materials Authorization (RMA) Form to receive replacement material and 2) Package the recalled Product to be returned and send to the address listed on the RMA form. For questions call Technical Support Team at 1-877-714-1924.

Device

Device Recall Wako Autokit Lp(a) Calibrator
  • Model / Serial
    Lot No.: DJ427, Exp 08-31-12
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product had been sold to 2 customers in the US.
  • Product Description
    Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics || 1600 Bellwood Road Richmond, VA 23237*** || Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.
  • 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