Events

Recall of Device Recall Waco Lipoprotein (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
    35885
  • Event Risk Class
    Class 3
  • Event Number
    Z-1409-06
  • Event Initiated Date
    2006-07-06
  • Event Date Posted
    2006-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47089
  • 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 (a) Calibrator - Product Code MMY
  • Reason
    Unexpected low cholesterol results-the cholesterol calibrator (lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.
  • Action
    The recalling firm notified consignees by phone and e-mail with an attached letter dated 07/06/06. The notification, flagged as ''Important Device Recall'' advised consignees to stop using the recalled product and that Lp(a) results showed a decrease in value of approximately 10% when the identified lots are used. Consignees were requested to return the enclosed response form for replacement product.

Device

Device Recall Waco Lipoprotein (a) Calibrator
  • Model / Serial
    Lots Numbers-EK560 EXP 7/31/06 and EH213 EXP 9/30/06
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The product was sold to one distributor and direct medical accounts Nationwide.
  • Product Description
    Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan
  • Manufacturer
    Wako Chemicals, USA Inc

Manufacturer

Wako Chemicals, USA Inc
  • Manufacturer Address
    Wako Chemicals, USA Inc, 1600 Bellwood Road, Richmond VA 23237-1326
  • Source
    USFDA