Events

Recall of SYNCHRON Systems Microalbumin (MA) Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter Inc..

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
    77138
  • Event Risk Class
    Class 2
  • Event Number
    Z-2124-2017
  • Event Initiated Date
    2017-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155017
  • 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
    Albumin, antigen, antiserum, control - Product Code DCF
  • Reason
    Beckman coulter has confirmed that ma reagent lot m609458 may recover outside the lower limit of the published insert range for beckman coulter urine protein control level 1.
  • Action
    Beckman Coulter sent an Urgent Medical Device Recall letter dated April 24, 2017, to affected customers to inform them that Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1. Internal testing has confirmed that MA is recovering within the published insert range for Beckman Coulter Urine Protein Control Level 2. Customers are informed of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to Customer Support Center via http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 in the United States and Canada, and outside US and Canada they are instructed to contact their local Beckman Coulter Representative.

Device

SYNCHRON Systems Microalbumin (MA) Reagent
  • Model / Serial
    M609458
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Guatemala, India, Italy, Japan, Mayotte, Mexico, Netherlands, Oman, Philippines, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.
  • Product Description
    Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL || MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA