Meth./Cali./Intru. Check for the Dimension System

• • Terminated Z-1654-2018 FDA Class II ·initiated 29 Jun 2017

  Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

• • Terminated Z-1662-2016 FDA Class II ·initiated 17 Mar 2016 ·on shared 510(k) K862359

  Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K862359 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Aca Iron Calibrator

  Class II

  FDA 510(k) K771802 Active Cleared 25 Oct 1977

• Du Pont Tobramycin Assay Reagents

  Class II

  FDA 510(k) K850058 Active Cleared 18 Jan 1985

• Du Pont Xenolite(Tm) Radiation Protection Apparel

  Class I

  FDA 510(k) K896511 Active Cleared 22 Dec 1989

• Aca Carbon Dioxide Calibrator

  Class II

  FDA 510(k) K771801 Active Cleared 25 Oct 1977

• Du Pont Aca Plus Immunoasssay System Hcg Calibrato

  Class II

  FDA 510(k) K922696 Active Cleared 12 Aug 1992

• Du Pont Analyst Analytical Test Rotor:CHEM-14, Cali

  Class II

  FDA 510(k) K901017 Active Cleared 15 May 1990

See all devices from E.I. Dupont DE Nemours & Co., Inc. →