Events

Recall of Device Recall Unicel Synchron Clinical Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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
    55163
  • Event Risk Class
    Class 2
  • Event Number
    Z-2441-2010
  • Event Initiated Date
    2010-01-18
  • Event Date Posted
    2010-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90198
  • 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 recall was initiated due to " a loose aliquot probe tube fitting in the closed tube aliquotter (cta), may result in erroneous access immunoassay results or synchron chemistry results". this may result in dilution of the sample with wash buffer; patient results can potentially be affected for access immunoassays or synchron chemistries. access quality control may also be affected if run throug.
  • Action
    Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated January 18, 2010, to all affected customers. The letter provided the customer with an explanation of the problem identified, the affected product, and instructions for the customer. The letter requested customers complete the following actions for : (1) CTA Aliquot Probe Inspection and Maintenance: a. Check daily for signs of leaks or damage to the tube fitting by looking and feeling for liquid at the fitting, the end of the probe and the surrounding areas; b. The CTA Aliquot Probe tube fitting should be checked to ensure that it is connected tightly to the Aliquot Probe. Without loosening the tube fitting, ensure it is securely tightened; c. When replacing the CTA Aliquot Probe, ensure that the Aliquot Probe tube fitting is securely tightened, prime the CTA, inspect for leaks, and run Access Quality Control through the CTA; d. If a leaking Aliquot Probe is suspected, review all sample results for both Access and Synchron in light of the total clinical presentation of the patient including: symptoms, clinical history, data from additional tests, and other appropriate information; e. As this issue may result in dilution of the sample with Wash Buffer; it may be appropriate to discard and redraw any affected sample tubes run on the CTA. The letter also informed customers that Beckman Coulter is currently evaluating potential solutions for this issue and requested they share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded the affected products to another laboratory, they were asked to provide a copy of this letter to them. They were also instructed to complete and return the enclosed response form within 10 days. Customers were told to call Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada with any questions.

Device

Device Recall Unicel Synchron Clinical Systems
  • Model / Serial
    All Serial Numbers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA: including the states of AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, AND WV and the country of Canada.
  • Product Description
    Closed Tube Aliquotter (CTA) for UniCel || DxC 600i, Part Number: A25637, Domestic; A25633, International || The UniCel Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA