Events

Recall of Access Immunoassay Systems Thyroglobulin

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
    57469
  • Event Risk Class
    Class 2
  • Event Number
    Z-2215-2011
  • Event Initiated Date
    2010-10-18
  • Event Date Posted
    2011-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96293
  • 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
    System,test,thyroglobulin - Product Code MSW
  • Reason
    The recall was initiated because in addition to access tg sample diluent, an additional diluent, access wash buffer ii, was added to thyroglobulin instructions for use (ifu) for evaluation of samples having tg levels above the reportable range of the assay. when customers interchange between diluents there is an unacceptable shift in results. a median difference of 16% (ranging from 14% to 23%) b.
  • Action
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 18, 2010, with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems Thyroglobulin. The letter describes the product, problem and actions to be taken. The customers were instructed to: 1. Do not dilute elevated thyroglobulin samples with Wash Buffer II. 2. Do not run thyroglobulin patient samples using the onboard dilution feature on the UniCel DxI instrument. 3. Dilute elevated thyroglobulin samples only with Access Thyroglobulin Sample Diluent (REF 33866). 4. Review your patient result archives. Manually dilute and repeat the analysis of all elevated thyroglobulin samples that had previously been diluted with Wash Buffer II, using Access Thyroglobulin Sample Diluent instead. 5. A forthcoming version of the UniCel DxI Assay Protocol File (APF) will remove the Access Thyroglobulin onboard dilution assay (dTg) from the list of available onboard dilution assays. 6. The Access Tg product Instructions for Use will be updated to eliminate Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples. Customers should update procedure manuals and other documents that your laboratory may have created which list Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples. In addition, customers were instructed to complete and return the enclosed PCA Response Form with in 10 days via fax to: 786-639-4000 or mail to: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs. Customers with any technical questions regarding the Product Corrective Action were instructed to contact Beckman's Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact their local Be

Device

Access Immunoassay Systems Thyroglobulin
  • Model / Serial
    All lot numbers
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Canada.
  • Product Description
    Access Immunoassay Systems Thyroglobulin, || Part Number: 33860 || This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.
  • 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