Dimension® Flex® Reagent Cartridge Phos
Phosphorus Flex® reagent cartridge, 480 tests
2manufacturers in China registered for this device type
1catalogue number
1recall
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 | CEO |
| Device type | Phosphomolybdate (Colorimetric), Inorganic Phosphorus |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1580 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2023-07-06 (version 5) |
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 |
|---|---|---|---|
| 10720277 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 13 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Pointe Scientific, Inc. Phosphorus | Horiba Instruments Incorporated | 6 |
| Carolina Liquid Chemistries Corp.® Phosphorus Reagent KIT AU-218 | Carolina Liquid Chemistries | 5 |
| JAS Diagnostics | Drew Scientific, Ltd. | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 4 |
| Phosphate (Inorganic) ver.2 | Roche Diagnostics Gmbh | 3 |
| Inorganic Phosphorous (Phos) | Randox Laboratories Limited | 3 |
| Pointe Phosphorus Reagent | Horiba Instruments Incorporated | 2 |
| Architect | Abbott Medical | 2 |
| Architect | Abbott Laboratories | 2 |
| Architect | Abbott Ireland | 2 |
Showing 12 of 40. All products under Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2013-02-22 | Class II | Device Design | Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close pro | 60,674 | 2015-01-29 |
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.