Events

Recall of Device Recall HemoCue Albumin 201 Analyzer

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

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
    63825
  • Event Risk Class
    Class 3
  • Event Number
    Z-0619-2013
  • Event Initiated Date
    2012-11-07
  • Event Date Posted
    2012-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114839
  • 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
    Turbidimetric method, protein or albumin (urinary, non-quant.) - Product Code JIQ
  • Reason
    Incorrect version of quick reference guide (qrg) was delivered with products in shipment made from april1 st 2011 and onwards. in addition, a warranty statement was missing in the analyzer package.
  • Action
    HemoCue sent an "IMPORTANT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Correction Notification Verification Form was included for customers to complete and return. Contact the firm at 562-668-5741 for questions regarding this notification.

Device

Device Recall HemoCue Albumin 201 Analyzer
  • Model / Serial
    See serial numbers of affected devices in attachment profided by firm.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
  • Product Description
    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. || The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.
  • Manufacturer
    HemoCue AB

Manufacturer

HemoCue AB
  • Manufacturer Address
    HemoCue AB, Kuvettgaten 1, Angelholm Sweden
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA