Events

Recall of Device Recall Shandon Rapid Chrome KwikDiff

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
    77011
  • Event Risk Class
    Class 2
  • Event Number
    Z-1895-2017
  • Event Initiated Date
    2017-03-15
  • Event Date Posted
    2017-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154823
  • 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
    Giemsa stain - Product Code HYF
  • Reason
    Methylene blue, solution #3 in the kwik diff kit was not methylene blue but crystal violet instead.
  • Action
    On 3/15/2017, URGENT MEDICAL DEVICE RECALL letters were sent to the affected consignees. 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. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER Please contact Richard Allan Scientific for directions on safe disposal or return if customers have affected lots. All other lots of the products, or similar products manufactured by Richard Allan Scientific, are unaffected. Upon identification of the affected lot, please notify Richard Allan Scientific of the quantity and the preferred disposal/return method. If product is being disposed of, evidence of disposal is required to be sent to Richard Allan Scientific. If affected product has been used with no issues, please notify Richard Allan Scientific of the quantity that is unavailable for return or disposal. Please use the attached Recall Return Response Acknowledgement & Receipt Form.

Device

Device Recall Shandon Rapid Chrome KwikDiff
  • Model / Serial
    Part Number: 9990700 Lot Number S-645, S-646 and S-647 Part Number 9990707 Lot: 234, 235, and 236  Expiration date: 8/18/2018-12/10/2018
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US: CA, CO, CT, DE, GA, HI, IA, IL, KS, MA, MS, NC, NH, NM, NY, OH, PA, PR, RI, UT, VA, VT, WA, and WV; and, the countries of AE, BH, CA, CZ, FR, GB, HK, SA, and TR.
  • Product Description
    Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 || Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 || Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. || Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. || Intended for use as a kit in special stain techniques.
  • 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