Events

Recall of Device Recall Histochemical PAS (Periodic Acid Schiff) Reaction Set'

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EMD Chemicals 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
    48640
  • Event Risk Class
    Class 3
  • Event Number
    Z-2303-2008
  • Event Initiated Date
    2008-06-02
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71778
  • 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
    Reagent, schiff - Product Code HZT
  • Reason
    Two complaints that kit was not performing properly with positive controls.
  • Action
    Distributors were notified of the recall on June 4, 2008 by e-mail, followed by a letter. The letter dated June 4, 2008, describes the problem, instructs customers to discontinue use of the product and contact EMD Chemicals for product replacement. An Important Product Recall form was also included in each letter, asking that the form be completed and returned to EMD. Contact EMD Chemicals Technical Service Department at 1-800-222-0342.A

Device

Device Recall Histochemical PAS (Periodic Acid Schiff) Reaction Set'
  • Model / Serial
    Item number 64945/93; Lot # 8055, Exp. August 31, 2009.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Histochemical PAS (Periodic Acid Schiff) Reaction Set' || Class I, IVD; || Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' || EMD Chemicals, Inc. || 480 S. Democrat Road, || Gibbstown, NJ 08027 || Each kit provides reagents sufficient for a maximum of 100 tests.
  • Manufacturer
    EMD Chemicals Inc

Manufacturer

EMD Chemicals Inc
  • Manufacturer Address
    EMD Chemicals Inc, 480 S Democrat Rd, Gibbstown NJ 08027-1239
  • Source
    USFDA