RAPIDPoint® 400 Measurement Cartridge
RAPIDPoint® 400 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct. For in vitro diagnostic use with RAPIDPoint ® 400 systems.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | GKF |
| Device type | Instrument, Hematocrit, Automated |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5600 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K002738 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | expiry date, serial number |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10329756 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 2 |
| RAPIDPOINT®340/350 pH Electrode | Siemens Healthcare Diagnostics Inc | 1 |
| UltraChek Reference Controls Low | Separation Technology, Inc. | 1 |
| Rapidpoint® 340/350 Valve Module | Siemens Healthcare Diagnostics Inc | 1 |
| UltraCrit (Refurbished) | Separation Technology, Inc. | 1 |
| UltraCrit Cuvettes | Separation Technology, Inc. | 1 |
| RAPIDSystems™ AutomaticQC Cartridge | Siemens Healthcare Diagnostics Inc | 1 |
| UltraChek Reference Controls High | Separation Technology, Inc. | 1 |
| UltraCrit Loaner | Separation Technology, Inc. | 1 |
| UltraCrit QC Cuvettes | Separation Technology, Inc. | 1 |
| UltraCrit | Separation Technology, Inc. | 1 |
| UltraChek Reference Controls Normal | Separation Technology, Inc. | 1 |
Recalls Naming This Product
5 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 | 2025-06-26 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate | 1,477 units | |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 492 units | 2020-07-16 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 828 units | 2015-04-01 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2009-10-30 | Not classified | Component design/selection | Software: Reference sensor failure may result in inaccurate pH reuslts | 998 units | 2015-09-04 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2009-10-30 | Not classified | Component design/selection | Software: Reference sensor failure may result in inaccurate pH reuslts | 4095 units | 2015-09-04 |
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.