Events

Recall of calcium membrane jackets

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
    58657
  • Event Risk Class
    Class 2
  • Event Number
    Z-2571-2011
  • Event Initiated Date
    2011-04-07
  • Event Date Posted
    2011-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99799
  • 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
    Electrode, ion, specific, calcium - Product Code JFP
  • Reason
    Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. this situation poses a risk to the safety of patients, particularly when the measurement results are used.
  • Action
    The firm, Radiometer America, sent a "MEDICAL DEVICE FIELD CORRECTION" letter dated April 14, 2011, to all affected customers. The letter describes the product, problem and the actions to be taken. The letter provides the customers with a series of steps to be taken when replacing the Calcium Membrane (Until further notice the above procedure must be carried out when replacing the Calcium membrane). The letter also provides quality control instructions for verifying calcium performance. Additionally, the customer is required to manually adjust the upper and lower QC limits on the analyzer in relation to the limits printed on the insert sheet in order to detect the bias during quality control measurements (This must be done for every lot of QC ampoules used, and for any new lot of ampoules installed). The letter asks that each customer complete and return the attached form via fax to 440-871-0463, in order to verify that the notification letter was received. Questions should be directed to the firm's Technical Support staff at 800-736-0600, Opt. 4.

Device

calcium membrane jackets
  • Model / Serial
    Part Numbers:  942-046, all lot numbers between 319 and 325  942-060, all lot numbers between 159 and 252
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV, and the countries of: Algir, argentina, Austria, Austrailia, Bahrain, Belarus, Belgium, Brazil, Brunei Darussalam, China, Columbia, Cuba, Greece, Denmark, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greenland, Guatemala, Hungary, India, Iraq, Ireland, Isreal, Italy, Jamaica, Japan, Kasakhstan, Kenya, Lebanon, Lithuania Korea, Malaysia, Malta, mexico, Moldavia, Nepal, New Zealand, Norway, Netherlands, Peru, Philipines, Poland, Portugal, Qatar, Oman, Rumania, Russia, Saudi Arabia, Singapore, Serbia and Kosvo, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Syria, Thailand, The Netherlands, Tunesia, Turkey, UK, Ukraine, United Arabia Emirates, Urguary, Usbekistan, and Venezuela.
  • Product Description
    Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. || Calcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700 Series and ABL800 Analyzers for InVitro testing of samples of whole blood for the parameters pH, PO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, CCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions: FO2Hb, FCOHb, FMetHb, FHHb andFHbF).
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA