Events

Recall of Device Recall Schiff

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
    36096
  • Event Risk Class
    Class 3
  • Event Number
    Z-0305-2007
  • Event Initiated Date
    2006-07-25
  • Event Date Posted
    2006-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47939
  • 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 KKS
  • Reason
    Due to loose caps, the so2 levels dropped significantly from release levels causing the product not to perform properly.
  • Action
    On July 27, 2006 EMD contacted its direct account customers via letter. The firm requested discontinue use of the product and contact EMD for return.

Device

Device Recall Schiff
  • Model / Serial
    Item Number 64945/93 Lot # 5341, Exp. Date: May 31, 2007.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. 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