Dimension Ahdl Flex Reagent Cartridge, Model: DF48B

• 2 recalls, same reason

  • Terminated Z-1663-2016 FDA Class II ·initiated 17 Mar 2016
  • Terminated Z-1659-2016 FDA Class II ·initiated 17 Mar 2016

  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

510(k) Number

K073072 ↗

FDA Product Code

JHM

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Tgl Flex Reagent Cartridge

  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

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