Rapidpoint® 350 Sensor Module
RAPIDPOINT® 350 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer
2manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
23recalls 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 | JGS |
| Device type | Electrode, Ion Specific, Sodium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1665 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K021515 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature 5 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10375812 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 13 |
| i-STAT | Abbott Point OF Care Inc. | 9 |
| AU | Beckman Coulter, Inc. | 8 |
| GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 | Instrumentation Laboratory SPA | 8 |
| Nova | Nova Biomedical Corporation | 6 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 5 |
| Sodium Electrode | Roche Diagnostics Gmbh | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Architect | Abbott Laboratories | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Sodium Electrode | Diamond Diagnostics Inc. | 3 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 2 |
Showing 12 of 88. All products under Electrode, Ion Specific, Sodium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222438 | 2023-07-25 |
| K161954 | 2017-03-09 |
| K151767 | 2015-12-11 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medica Corp. | 510(k) number | 2025-12-31 | Class II | Nonconforming Material/Component | A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes. | 1,578 units |
Recalls
20 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 |
|---|---|---|---|---|---|
| 2025-07-07 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias obse | 37,554 units | |
| 2023-09-26 | Class II | Under Investigation by firm | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels wi | 12,363 units | |
| 2023-09-26 | Class II | Under Investigation by firm | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels wi | 8,749 units | |
| 2021-11-18 | Class II | Software design | (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Boa | 2,980 units | |
| 2021-05-18 | Class II | Software design | ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed p | 842 units | 2024-08-30 |
| 2021-05-13 | Class II | Component design/selection | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject t | US: 210 OUS: 874 | |
| 2021-05-04 | Class II | Device Design | Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results | 2,153 units | |
| 2020-12-02 | Class II | Under Investigation by firm | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results | 2405 units | 2024-06-06 |
| 2020-02-27 | Class II | Under Investigation by firm | Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilut | 1807 | 2021-10-25 |
| 2020-01-12 | Class II | Under Investigation by firm | Some lots ending in “17”, “18”, “19”, or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results. | 3559 | |
| 2019-10-11 | Class II | Under Investigation by firm | On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the syste | 1528 | 2021-05-03 |
| 2019-07-30 | Class II | Software design | Atellica CH 930 Analyzer – Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below | 1125 units | 2022-06-10 |
| 2019-03-07 | Class II | Under Investigation by firm | There were multiple issues identified in the system software which required an update. | 474 | 2020-08-20 |
| 2018-02-26 | Class II | Software design | When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers | 2020-05-12 | |
| 2015-08-28 | Class II | Device Design | ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC will fail if the ele | Domestic: 15 units; Foreign: 59 units | 2018-05-22 |
| 2015-02-11 | Class II | Software design | Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The system may cause samples to remain in an Inprocess state. Test results on a sample that is held Inprocess will not transmit to the | 16 units: 3 Domestic, 13 Foreign | 2017-03-02 |
| 2013-09-03 | Class II | Software design | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems. | 892 units | 2017-03-07 |
| 2013-09-03 | Class II | Software design | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems. | 1366 units | 2017-03-07 |
| 2013-09-03 | Class II | Software design | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems. | 876 units | 2017-03-07 |
| 2013-09-03 | Class II | Software design | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems. | 625 units | 2017-03-07 |
| 2006-02-17 | Not classified | Other | Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determ | 1138 for all products | 2012-05-24 |
| 2006-02-17 | Not classified | Other | Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determ | 1138 for all products | 2012-05-24 |
| 2006-02-17 | Not classified | Other | Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determ | 1138 for all products | 2012-05-24 |
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.