Dimension Vista® Flex® Reagent Cartridge Lipl
Liquid Lipase Flex® reagent cartridge, 480 tests
2manufacturers in China registered for this device type
1catalogue number
6recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | CHI |
| Device type | Lipase-Esterase, Enzymatic, Photometric, Lipase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1465 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2024-06-19 (version 4) |
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 |
| Distribution end date | 2024-06-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10461745 | 4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 7 |
| Lipase (LPS) | Randox Laboratories Limited | 4 |
| Carolina Liquid Chemistries Corp.® Lipase Reagent KIT ST621 | Carolina Liquid Chemistries | 4 |
| Lipase colorimetric assay | Roche Diagnostics Gmbh | 3 |
| Architect | Abbott Ireland | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Pointe Scientific, Inc. Lipase-Color | Horiba Instruments Incorporated | 2 |
| Alinity | Abbott Ireland | 2 |
| Architect | Abbott Laboratories | 1 |
| MedTest Dx, Inc. Lipase (Colorimetric) | Medtest DX | 1 |
| Lipase NG OC Reagent Kit | Sentinel CH. SPA | 1 |
| Lipase colorimetric | Roche Diagnostics Gmbh | 1 |
Showing 12 of 28. All products under Lipase-Esterase, Enzymatic, Photometric, Lipase
Recalls
5 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 | Closed |
|---|---|---|---|---|---|
| 2019-12-20 | Class II | Under Investigation by firm | Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product. | 3224 | 2020-12-21 |
| 2018-09-07 | Class II | Under Investigation by firm | There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. | 18396 | 2020-11-16 |
| 2018-09-07 | Class II | Under Investigation by firm | There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. | 3956 | 2020-11-16 |
| 2017-12-14 | Class II | Under Investigation by firm | Calibration failure – confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits. | 2020-12-03 | |
| 2015-03-23 | Class II | Device Design | Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycer | 7814 | 2015-12-18 |
| 2010-03-10 | Not classified | Other | Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration. | 21171 | 2011-08-04 |
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.