Atellica A-Lyte™ Integrated Multisensor Na+ / K+ / Cl-
A-LYTE™ IMT (Na K Cl) Atellica CH - RGT
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) | K151767 |
| Record published | 2017-12-22 |
| Record revised | 2025-06-06 (version 6) |
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 |
|---|---|---|---|
| 11099315 | 4 | 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
7 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 | 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 | |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 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 | |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 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 | |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 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 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 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 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 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 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 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 |
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.