Events

Recall of Device Recall TDx/TDxFlx Cyclosporine Monoclonal Whole Blood Calibrators & Controls

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Health Products, 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
    32890
  • Event Risk Class
    Class 2
  • Event Number
    Z-0624-06
  • Event Initiated Date
    2005-03-23
  • Event Date Posted
    2006-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41034
  • 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
    Fluroesence Polorization Immunoassay For Cyclosporine - Product Code MGU
  • Reason
    Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. an important product information letter with technical information regarding the whole blood calibrators and controls, implementing new internal reference standards was issued.
  • Action
    Abbott has recently implemented new internal reference standards for TDx/TDxFLx Cyclosporine monoclonal Whole Blood Calibrators and Controls. A change in performance is associated with the use of calibrator lots 1829Q100 and higher and control lots 18230Q100 and higher, which are the first lots manufactured using the new internal reference standards. The specific performance changes are identified in the letter, dated March 23, 2005, as compared to current product using the previous standards (calibrators lot 05434Q100 and control lot 03071Q100).

Device

Device Recall TDx/TDxFlx Cyclosporine Monoclonal Whole Blood Calibrators & Controls
  • Model / Serial
    Lot 18229Q100 (exp 8/26/2006) Lot 18230Q100 (exp 10/05/2006)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Puerto Rico, Hawaii, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Canada, Germany, Japan , Singapore, India, Taiwan, Thailand, Korea, Australia, Honduras, and Panama,
  • Product Description
    In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test || TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. || TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).
  • Manufacturer
    Abbott Health Products, Inc.

Manufacturer

Abbott Health Products, Inc.
  • Manufacturer Address
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Cruze Davila, Barceloneta PR 00617
  • Source
    USFDA