Dimension Lipase (LIP) Flex Reagent Cartridge
Dimension Lipase (LIP) Flex reagent cartridge, 120 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 | 2021-11-11 |
| Record revised | 2023-07-06 (version 2) |
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 |
|---|---|---|---|
| 11538126 | 4 | In distribution |
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 |
| Dimension Vista® Flex® reagent cartridge Lipl | Siemens Healthcare Diagnostics Inc | 1 |
| MedTest Dx, Inc. Lipase (Colorimetric) | Medtest DX | 1 |
| Lipase NG OC Reagent Kit | Sentinel CH. SPA | 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.