Colorimetric Method, Lipoproteins
Clinical Chemistry · 21 CFR 862.1475
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
4 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.Open, ClassifiedOct 14, 2022
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.
Z-0089-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedUnknown
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), variou
Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.
Z-1188-2021 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Dimension Assays: Direct HDL Cholesterol (AHDL)
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
Z-1659-2016 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
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
Z-1663-2016 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Abaxis, Inc.Apr 24, 2012
K120662 · PICCOLO HDL-CAPILLARY TEST SYSTEM
- Siemens Healthcare DiagnosticsJul 2, 2008
K081300 · DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
- Dade Behring, Inc.Feb 21, 2008
K073072 · DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
- Dade Behring, Inc.Oct 30, 2003
K032798 · DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
- Jas Diagnostics, Inc.Sep 30, 2002
K022519 · LDL CHOLESTEROL (AUTOMATED)
- Dade Behring, Inc.Jan 11, 1999
K983849 · DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
- Roche Diagnostic Systems, Inc.Sep 27, 1990
K902935 · ROCHE COBAS READY HDL CHOLESTEROL REAGENT
- Medical Specialties, Inc.May 1, 1984
K841056 · HDL PRECIPITANT REAGENT SET