Events

Recall of Device Recall Qualicheck Level 2 control solution

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America 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
    35773
  • Event Risk Class
    Class 3
  • Event Number
    Z-1316-06
  • Event Initiated Date
    2005-05-24
  • Event Date Posted
    2006-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46846
  • 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
    package insert - Product Code GKF
  • Reason
    The package insert, which accompanied the qc reagents used with abl blood gas analyzers, referenced incorrect control ranges for hct (hematocrit) testing. the range stated on the package insert was too low to generate accurate hct test results (the control ranges were acceptable for the glucose and lactate testing).
  • Action
    The firm apprised their customers of this situation with a letter dated 5/24/2005. The letter requests that the customer remove the old (incorrect) package insert and replace it with a new (correct) insert which accompanied the customer letter. Should the customer have any questions, or need additional package inserts, the letter provides a toll-free contact telephone number.

Device

Device Recall Qualicheck Level 2 control solution
  • Model / Serial
    Model #.S7180, Part Number: 944040, Lot #15.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including: PA, MI, NY, OH, NJ, TX, AL, MO, AR, TN, WA, KY, and NC, and London, ON, Canada
  • Product Description
    Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA