Events

Recall of Device Recall IVD calibrator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kamiya Biomedical Company, LLC.

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
    53750
  • Event Risk Class
    Class 2
  • Event Number
    Z-0973-2010
  • Event Initiated Date
    2009-05-01
  • Event Date Posted
    2010-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86462
  • 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
    The long-term stability of level 2 (1.0 mg/dl) may not be within the specifications due to a decrease in crp concentration.
  • Action
    On May 1, 2009 the recalling firm, Kamiya Biomedical Company contacted the 3 consignees by telephone and notified them of the issue. A follow-up e-mail notification on May 4, 2009 was sent to consignees requesting to return the affected product to Kamiya Biomedical Company for a free replacement kit. After the e-mail notifications, an Urgent Medical Device Recall Notice dated May 13, 2009 was also sent to consignees describing the issue and actions to take for returning opened and unopened affected product to the recalling firm for replacement. Direct questions to the Kamiya Biomedical Company by calling 1- 206-575-8068.

Device

Device Recall IVD calibrator
  • Model / Serial
    Catalog number: "KAI-084C", Lot # "559011"
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States (NY, NJ, and NC).
  • Product Description
    "K-ASSAY CRP (3) Calibrator E". || This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use.
  • Manufacturer
    Kamiya Biomedical Company, LLC

Manufacturer

Kamiya Biomedical Company, LLC
  • Manufacturer Address
    Kamiya Biomedical Company, LLC, 12779 Gateway Dr S, Tukwila WA 98168-3308
  • Manufacturer Parent Company (2017)
    Kamiya Biomedical Company Llc
  • Source
    USFDA