Ferr Flex Reagent Cartridge

• • Terminated Z-2229-2019 FDA Class II ·initiated 15 Jul 2019

  Negative Bias with Lot EA9227.

• • Terminated Z-2238-2014 FDA Class II ·initiated 15 Jul 2014

  Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv

• • Terminated Z-0561-2014 FDA Class II ·initiated 6 May 2013

  Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l

510(k) Number

K963498 ↗

FDA Product Code

JMG

Device Class

Class II

Regulation

21 CFR Part 866.5340

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Prostate Specific Antigen (PSA) Calibrator

  Class II

  FDA 510(k) K973100 Active Cleared 29 Sep 1997

• Human Chorionic Gonadotropin Calibrator

  Class II

  FDA 510(k) K970396 Active Cleared 20 Feb 1997

• Thyroid Stimulating Hormone Method

  Class II

  FDA 510(k) K970393 Active Cleared 3 Mar 1997

• Troponin (Trop) Method

  Class II

  FDA 510(k) K973650 Active Cleared 20 Oct 1997

• Mmb Method

  Class II

  FDA 510(k) K970343 Active Cleared 14 Feb 1997

• Human Chorionic Gonadotropin Method

  Class II

  FDA 510(k) K970387 Active Cleared 10 Mar 1997

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