RAPIDSystems™ AutomaticQC Cartridge
for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only.
2manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | CEM |
| Device type | Electrode, Ion Specific, Potassium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1600 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K002738 |
| Record published | 2017-01-23 |
| Record revised | 2021-11-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature 2 to 25 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11046781 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nova | Nova Biomedical Corporation | 8 |
| Stat Profile | Nova Biomedical Corporation | 7 |
| Potassium electrode | Roche Diagnostics Gmbh | 4 |
| Potassium Electrode | Diamond Diagnostics Inc. | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Architect | Abbott Laboratories | 3 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 2 |
| I.S.E. K | Randox Laboratories Limited | 2 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| Potassium Electrode | Medica Corp. | 2 |
| Na/K Solution Pack | Medica Corp. | 2 |
| Selectra | VitalScientific B.V. | 2 |
Showing 12 of 93. All products under Electrode, Ion Specific, Potassium
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 |
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 |
|---|---|---|---|---|---|
| 2015-02-24 | Class II | Under Investigation by firm | A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. The dilution check correction would be detected by QC; however, if not det | 5981 | 2017-02-01 |
| 2010-08-19 | Not classified | Other | High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System. | 3,706 cartons | 2010-10-26 |
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.