Events

Recall of KASSAY

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kamiya Biomedical 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
    35169
  • Event Risk Class
    Class 3
  • Event Number
    Z-0850-06
  • Event Initiated Date
    2006-04-11
  • Event Date Posted
    2006-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45460
  • 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
    C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
  • Reason
    Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent.
  • Action
    Customers were contacted via telephone on 4/11/06. Customers were asked to confirm the number of kits in their possession and then open the kits to verify which vials they received in their kits. If the kits contained both vials, then the customer was instructed to keep the kit. If the kits contained the wrong vials, then they were requested to return the kits. This was followed by a letter dated 4/17/06. The letter confirmed the telephone call and asked the customer to sign and return the letter to acknoweldge receipt of the letter.

Device

KASSAY
  • Model / Serial
    Lot No.: 666011 EXP.: 07/2007
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Kits were distributed to laboratories nationwide. One foreign account in Singapore.
  • Product Description
    K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP(2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap.
  • Manufacturer
    Kamiya Biomedical Company

Manufacturer

Kamiya Biomedical Company
  • Manufacturer Address
    Kamiya Biomedical Company, 12779 Gateway Dr., Seattle WA 98168
  • Source
    USFDA