Events

Recall of Device Recall Richard Allan Scientific 10 Neutral Buffered Formalin

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
    74557
  • Event Risk Class
    Class 2
  • Event Number
    Z-2351-2016
  • Event Initiated Date
    2016-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147901
  • 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
    Formalin, neutral buffered - Product Code IFP
  • Reason
    Potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. it is unknown whether the contamination will affect tissue antigenicity. if it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. there is the possibility the patient may need to be re-biopsied.
  • Action
    On 6/13/2016, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via certified mail with instructions for identifying and disposing of the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

Device

Device Recall Richard Allan Scientific 10 Neutral Buffered Formalin
  • Model / Serial
    Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of FL, PA, NY, MD, CA, and AZ.
  • Product Description
    Richard Allan Scientific 10% Neutral Buffered Formalin, || Part Number: 53901 and 561201 || Item 53901 90ml bottle, 125 per case; || Item 561201 120ml bottle, 75 per case.
  • 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