Dimension® Flex® Reagent Cartridge Ahdl
High Density Lipoprotein Cholesterol Flex® reagent cartridge, 240 tests
1manufacturer
1catalogue number
1510(k) clearance
4recalls on this code
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JHM |
| Device type | Colorimetric Method, Lipoproteins |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K073072 |
| Record published | 2020-09-24 |
| Record revised | 2023-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10464332 | 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 20 |
| JAS Diagnostics | Drew Scientific, Ltd. | 2 |
| Dimension Vista® Flex® reagent cartridge Hdlc | Siemens Healthcare Diagnostics Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K081300 | 2008-07-02 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2016-03-17 | Class II | Device Design | 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 | 137422 units total | 2017-09-25 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2016-03-17 | Class II | Device Design | 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 | 137422 units total | 2017-09-25 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-08-24 | Class II | Under Investigation by firm | 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 | 1592 units |
| 2021-02-03 | Class II | Under Investigation by firm | 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 20062B | 4174 devices (Domestic: 2836 devices, Foreign: 1338 devices) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.