Events

Recall of KASSAY Alpha1 Microglobulin Reagent

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
    50074
  • Event Risk Class
    Class 3
  • Event Number
    Z-0923-2011
  • Event Initiated Date
    2008-09-17
  • Event Date Posted
    2011-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74651
  • 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
    Alpha-1 microglobulin, antigen, antiserum, control - Product Code MGA
  • Reason
    Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.
  • Action
    Kamiya Biomedical Company, LLC sent an urgent medical Device Recall letter dated September 17, 2008, and the corrected package insert via e-mail. . The letter identified the product, the problem, and the action the customer should take. Customers were instructed to replace their previous package inserts with the corrected version and asked to sign and FAX the letter back once that had been completed. As one customer is also a distributor, the recalling firm told the this distributor's representative to advise their single customer of this correction and replace the package insert, and return the signed letter back to the firm. On September 22, 2008, both customers were contacted by phone and reminded to fax the signed letters once completed. For questions regarding this recall call 1-800-222-0342.

Device

KASSAY Alpha1 Microglobulin Reagent
  • Model / Serial
    Lot number 418041, catalog number KAI-056.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.
  • Product Description
    K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. || The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".
  • 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