Events

Recall of Device Recall Qualicheck 1, Aqueous Quality Control, Level 2, S7140, REF 944042.

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
    37530
  • Event Risk Class
    Class 3
  • Event Number
    Z-0608-2013
  • Event Initiated Date
    2006-06-06
  • Event Date Posted
    2012-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50686
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    The barcode for the abl77 on the insert incorrectly enters a control range for ph of 7.90-7.95 into the analyzer. the insert correctly states that the control range is 7.40-7.45.
  • Action
    Radiometer sent Field Action Notes regarding the affected product. The note identified the product, the problem and the action to be taken by the customer. Instead of scanning the barcorde on the insert to enter the QC data into the anyalyzer, customers were instructed to manually key in the QUALICHECK type, lot number, and correct control range. For questions regarding this recall call 440-871-8900.

Device

Device Recall Qualicheck 1, Aqueous Quality Control, Level 2, S7140, REF 944042.
  • Model / Serial
    Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to KY, NC, and NY.
  • Product Description
    Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. || The solution is used for quality check of blood gas analyzers.
  • Manufacturer
    Radiometer America Inc

Manufacturer

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