Events

Recall of Device Recall Paraffin Wax

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Richard-Allan Scientific Company.

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
    73334
  • Event Risk Class
    Class 3
  • Event Number
    Z-1319-2016
  • Event Initiated Date
    2016-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144179
  • 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
    Apparatus, melting point, paraffin - Product Code IDT
  • Reason
    Multiple complaints were received from customers indicating that they ordered product 8335(type 3 paraffin) but when they opened the box, they found product 8336 (type 6 paraffin) inside.
  • Action
    ThermoFisher sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 15, 2016, to all affected customers. The letter contained the following instructions: If you have the above lot in your possession, please determine whether the bags are labeled as Type 3 (PN 8335) or Type 6 (PN 8336). ¿ If the product is labeled as Type 3 (PN 8335) please complete the attached Response form with the quantity in inventory and return the form to Richard-Allan Scientific. The product may be used and no further action is required. ¿ If the product is labeled as Type 6 (PN 8336) please complete the attached Response form with the quantity in inventory. The product may be used as is or returned to Richard-Allan Scientific. Please indicate on the Response form if the product will be used or a return is desired. Return the completed form to Richard-Allan Scientific. ¿ If affected product has been used previously, please complete the attached Response form with the quantity that was used. No further action is required. By returning the attached Acknowledgment Form will facilitate reporting of this matter to the FDA. Customers with questions were instructed to call 269-544-5628.

Device

Device Recall Paraffin Wax
  • Model / Serial
    Product code: 8335 and lot code: 348248
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution to AZ , CA , FL , GA , IL , MI , MN , NM , NY , OH , TX , UT and Internationally to Germany and the United Kingdom. 6 distributed to OUS accounts: Germany, and the United Kingdom
  • Product Description
    Richard-Allan Scientific Paraffin Type 3 || For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place
  • Manufacturer
    Richard-Allan Scientific Company

Manufacturer

Richard-Allan Scientific Company
  • Manufacturer Address
    Richard-Allan Scientific Company, 4481 Campus Dr, Kalamazoo MI 49008-2590
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA