Events

Recall of Membrane box for CREA A and CREA B

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
    69813
  • Event Risk Class
    Class 2
  • Event Number
    Z-1293-2015
  • Event Initiated Date
    2014-10-29
  • Event Date Posted
    2015-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131577
  • 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 based, enzymatic, creatinine - Product Code CGL
  • Reason
    Negative drift on qc during in-use lifetime of crea membranes can be observed.
  • Action
    Radiometer sent a Product Notification letter dated November 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to perform the following steps immediately: " Perform one quality control measurement using S7835 AutoCheck 6+, level 1 on already installed Crea membrane units to verify the Crea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Until further notice the following must be carried out every 24 hours: " Perform one quality control measurement using S7835 AutoCheck 6+, level 1 to verify the Crea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Please do not report Crea results unless the membrane unit has been verified as described above. If you already run S7835 AutoCheck 6+ level 1, every 24 hours, as part of your regular QC schedule, you do not need to do anything additional. Please review your QC results to ensure the results are within the QC range. Please complete and return the attached fax form, with your signature as soon as possible or within 7 days. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900, ext 209.

Device

Membrane box for CREA A and CREA B
  • Model / Serial
    Model Number 942-073; all lots which have not expired their product lifetime which would be lot 972-073R0465 and onward: Affected lot numbers 942-073R0465 942-073R0468 942-073R0469 942-073R0470 942-073R0471 942-073R0472 942-073R0474 942-073R0475 942-073R0476 942-073R0478 942-073R0479 942-073R0480 942-073R0481 942-073R0482 942-073R0487 942-073R0488 942-073R0489 942-073R0490 942-073R0491 942-073R0492 942-073R0493 942-073R0494 942-073R0495 942-073R0496 942-073R0497 942-073R0498 942-073R0499 942-073R0500 942-073R0501 942-073R0502 942-073R0503 942-073R0504 942-073R0507 942-073R0509 942-073R0510 942-073R0511 942-073R0512 942-073R0513 942-073R0515 942-073R0518 942-073R0520 942-073R0521 942-073R0522 942-073R0523 942-073R0524 942-073R0525 942-073R0526 942-073R0527 942-073R0528 942-073R0529 942-073R0530 942-073R0532 942-073R0533 942-073R0534 942-073R0535 942-073R0536 942-073R0537 942-073R0538 942-073R0539 942-073R0540 942-073R0541 942-073R0542 942-073R0544 942-073R0545 942-073R0546 942-073R0548 942-073R0549 942-073R0550 942-073R0551 942-073R0553 942-073R0555 942-073R0556 942-073R0557 942-073R0558 942-073R0560 942-073R0561 942-073R0562 942-073R0564 942-073R0565 942-073R0566 942-073R0567 942-073R0569 And onwards: The firm is still determining the scope of how many lot numbers are affected.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including NM, NC, TN, OH, NE, CA, MO, GA, MA, TX, WV, PA, NY, VA, MN, IN, ME, MD, IL, MI, KS, WI, FL, WA, CT, OK, CO, and Internationally to Canada, Denmark, Spain, Italy, India, Sweden, Germany, Australia, Hungary, Great Britain, Norway, Uruguay, France, Poland, Switerland, Russian Federation, Netherlands, Czech Republic, Mexico, Brazil, Czechoslovakia, Austria, Singapore, Syria, Phillipines, Egypt, Bolivia, Japan, New Zealand, Turkey, Saudi Arabia, Algeria, Qatar, and Finland.
  • Product Description
    Crea A and B membranes, packaged 4 per box || Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA