Events

Recall of Device Recall 10 Buffered Formalin Phosphate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ThermoFisher Scientific Co., LLC.

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
    48601
  • Event Risk Class
    Class 2
  • Event Number
    Z-2159-2008
  • Event Initiated Date
    2008-05-01
  • Event Date Posted
    2008-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71704
  • 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
    Neutral Buffered Formalin - Product Code IFP
  • Reason
    Assay tests on retention sample of 10% buffered formalin phosphate showed it to be 3.417%, which is below the specification of 4-5%.
  • Action
    Urgent: Product Recall notification letters were sent by US mail on May 1, 2008. The letters asked that those in receipt of the product check their stock for this product, destroy any of the material that remains from the referenced lot, and then contact their local customer service center for a replacement. The letter also states that the appropriate corrective measures have already been instituted to prevent a recurrence.

Device

Device Recall 10 Buffered Formalin Phosphate
  • Model / Serial
    Lot 075923
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and Canada.
  • Product Description
    10% Buffered Formalin Phosphate; Certified || For laboratory and manufacturing use only, not for drug, food or household use. || Do not Transfer to an unmarked container. || Catalog numbers: SF100-4, SF100-20 || Fisher Scientific, Fail Lawn, NJ 07410
  • Manufacturer
    ThermoFisher Scientific Co., LLC

Manufacturer

ThermoFisher Scientific Co., LLC
  • Manufacturer Address
    ThermoFisher Scientific Co., LLC, 1 Reagent Ln, Fair Lawn NJ 07410-2802
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA