Dimension Tacr Flex Reagent Cartridge, Model DF107

• • Terminated Z-1924-2013 FDA Class II ·initiated 1 Jul 2013

  Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.

• • Terminated Z-0957-2013 FDA Class II ·initiated 27 Nov 2012

  Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values

• • Terminated Z-2407-2010 FDA Unclassified (pre-2012) ·initiated 15 Jun 2010

  Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.

510(k) Number

K060502 ↗

FDA Product Code

MLM

Device Class

Class II

Regulation

21 CFR Part 862.1678

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Apolipoprotein Control Serum Chd, Model Ouph

  Class I

  FDA 510(k) K993310 Active Cleared 30 Nov 1999

• Dade Tru-Liquid Cardiac Control

  Class I

  FDA 510(k) K981622 Active Cleared 8 Jun 1998

• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

  Class II

  FDA 510(k) K033487 Active Cleared 24 Dec 2003

• Behring Coagulation System, Model BCS

  Class II

  FDA 510(k) K002080 Active Cleared 16 Nov 2000

• Modification to N Protein Standard Sl

  Class II

  FDA 510(k) K012470 Active Cleared 28 Sep 2001

• Tgl Flex Reagent Cartridge

  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

See all devices from Dade Behring, Inc. →