Immulite Free T3

• 2 recalls, same reason

  • Terminated Z-0868-2014 FDA Class II ·initiated 27 Aug 2013
  • Terminated Z-0867-2014 FDA Class II ·initiated 27 Aug 2013

  Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits. A positive bias in quality control results was also observed, but the values may remain within the established ranges.

510(k) Number

K974634 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Diagnostic Products Corp. →

• What is the primary function of the Immulite Free T3?

  The Immulite Free T3 is a solid-phase, chemiluminescent enzyme immunoassay designed to measure free T3 levels in clinical chemistry applications. It is specifically optimized to maintain the equilibrium between free and protein-bound T3 during the testing process.

• Which equipment is required to use this assay?

  This assay is designed for use exclusively with the Immulite Automated Immunoassay Analyzer. It functions as a radioimmunoassay for total triiodothyronine within that specific system.

• What is the regulatory status of the Immulite Free T3?

  The Immulite Free T3 has received FDA 510(k) clearance. It is classified as a Class II medical device under regulation number 862.1710, which pertains to clinical chemistry applications.