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Colorimetric Method, Lipoproteins
FDA product code JHM · Class 1 · Clinical Chemistry
24
Registered devices
0
Adverse events
4
Recalls
9
510(k) clearances
Devices with this code
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Dimension Vista® Flex® reagent cartridge HDLC — Siemens Healthcare Diagnostics Inc.Dimension® Flex® reagent cartridge AHDL — Siemens Healthcare Diagnostics Inc.JAS Diagnostics — DREW SCIENTIFIC, INC.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.JAS Diagnostics — DREW SCIENTIFIC, INC.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-24 | Siemens Healthcare Diagnostics, Inc. | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Rea |
| 2021-02-03 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vist |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. |
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