Events

Recall of Device Recall CYTOSTAIN

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
    70562
  • Event Risk Class
    Class 3
  • Event Number
    Z-1264-2015
  • Event Initiated Date
    2015-02-19
  • Event Date Posted
    2015-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134052
  • 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
    Stain, papanicolau - Product Code HZJ
  • Reason
    The case was correctly labeled as ref 7501r, however the gallon bottle was incorrectly labeled as ref 7501g cyto-stain g. the bottle label has the correct lot number of 313833 and exp date 11/2016. the gallon bottle contains the correct intended contents of 7501r: cyto-stain r stain.
  • Action
    Urgent Medical Device Recall letters sent to Richard Allan distributors and customers. The recall notification includes the reason for the voluntary recall, risk to health, product information and actions to be taken by the distributor/customer.

Device

Device Recall CYTOSTAIN
  • Model / Serial
    Lot: 313833 Expiration date: 11/2016
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada and Europe
  • Product Description
    Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.
  • 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