Dimension (Tm) Clinical Chemistry System

• • Ongoing Z-1816-2022 FDA Class II ·initiated 17 Aug 2022 ·on shared 510(k) K861700

  Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur

• • Terminated Z-1049-2013 FDA Class II ·initiated 22 Feb 2013 ·on shared 510(k) K861700

  Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.

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

510(k) Number

K861700 ↗

FDA Product Code

CHH

Device Class

Class I

Regulation

21 CFR Part 862.1175

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. →