Events

Recall of Device Recall Quantikine IVD Human sTfR Immunoassay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by R & D Systems, 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
    75016
  • Event Risk Class
    Class 2
  • Event Number
    Z-2887-2016
  • Event Initiated Date
    2016-08-24
  • Event Date Posted
    2016-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149122
  • 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
    Immunochemical, Transferrin - Product Code JNM
  • Reason
    R&d; systems, inc. received two customer complaints that results of the controls provided with the quantikine¿ ivd¿ human stfr immunoassay kit were out of the range high. internal testing within r&d; systems confirmed a problem with control results being out of range high.
  • Action
    Consignees were sent via US mail on 8/24/2016 a R&D; systems "Urgent Medical Device Recall" letter dated August 23, 2016. The letter described the problem and the product involved in the recall. Advised consignees to stop using the kits and to discard all unused kits and complete and return the enclosed Acknowledgement and Receipt Form. For questions contact Bio-Technes Technical Service Department at 1-612-379-2956 or techserv@bio-techne.com.

Device

Device Recall Quantikine IVD Human sTfR Immunoassay
  • Model / Serial
    331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA. OUS: AUSTRALIA, China, INDIA, INDONESIA, ISRAEL, JAPAN, MEXICO, SOUTH KOREA, UNITED KINGDOM.
  • Product Description
    R&D; Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
  • Manufacturer
    R & D Systems, Inc.

Manufacturer

R & D Systems, Inc.
  • Manufacturer Address
    R & D Systems, Inc., 614 McKinley Pl NE, Minneapolis MN 55413-2610
  • Manufacturer Parent Company (2017)
    R & D Systems Inc
  • Source
    USFDA