Aptio Automation
The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The…
The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation.
2manufacturers in China registered for this device type
1catalogue number
24recalls 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 | Inpeco SA, Switzerland |
|---|---|
| FDA product code | CEM |
| Device type | Electrode, Ion Specific, Potassium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1600 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K121012 |
| Record published | 2016-09-24 |
| Record revised | 2024-10-14 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AP2 | 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
24 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 |
|---|---|---|---|---|---|---|---|
| Inpeco SA | 510(k) number | 2025-10-30 | Class II | Device Design | The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform | 1 unit (OUS only) | |
| Inpeco SA | 510(k) number | 2025-10-30 | Class II | Device Design | The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform e | 14 units (1 US, 13 OUS) | |
| Inpeco SA | 510(k) number | 2025-09-03 | Class II | No Marketing Application | The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may caus | 8 units | |
| Inpeco SA | 510(k) number | 2025-09-03 | Class II | No Marketing Application | The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may ca | 1 unit | |
| Inpeco SA | 510(k) number | 2023-11-03 | Class II | Software Design Change | Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing. | 1 unit US: 14 units OUS | |
| Inpeco SA | 510(k) number | 2023-03-10 | Class II | Under Investigation by firm | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment | US:245 (16 FlexLab systems, 121 Accelerator a3600 system, 10 | |
| Inpeco SA | 510(k) number | 2023-03-10 | Class II | Under Investigation by firm | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment | US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 1 | |
| Inpeco SA | 510(k) number | 2023-03-10 | Class II | Under Investigation by firm | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment | US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 1 | |
| Inpeco SA | 510(k) number | 2023-03-10 | Class II | Under Investigation by firm | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment | US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 1 | |
| Inpeco SA | 510(k) number | 2023-03-10 | Class II | Under Investigation by firm | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment | US:245 (16 FlexLab systems, 121 Accelerator a3600 system, 10 | |
| Inpeco SA | 510(k) number | 2021-09-10 | Class II | Software design | The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result. | 262 total, 52 US | |
| Inpeco SA | 510(k) number | 2020-08-07 | Class II | Software design | Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results | 2 US and 6 OUS | 2021-12-02 |
| Inpeco SA | 510(k) number | 2020-08-07 | Class II | Software design | Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results | 2 US and 6 OUS | 2021-12-02 |
| Inpeco SA | 510(k) number | 2020-08-07 | Class II | Software design | Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results | 10 US and 22 OUS | 2021-12-02 |
| Inpeco SA | 510(k) number | 2020-07-14 | Class II | Software design | When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 a | 93 | 2023-12-28 |
| Inpeco SA | 510(k) number | 2020-07-14 | Class II | Software design | When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 a | 136 | 2023-12-28 |
| Inpeco SA | 510(k) number | 2020-07-14 | Class II | Software design | When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 a | 104 | 2023-12-28 |
| Inpeco SA | 510(k) number | 2020-04-07 | Class II | Software design | When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples. | 82 | 2022-07-28 |
| Inpeco SA | 510(k) number | 2020-04-07 | Class II | Software design | When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples. | 273 | 2022-07-28 |
| Inpeco SA | 510(k) number | 2020-04-07 | Class II | Component design/selection | The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design. | 10 systems | 2024-06-13 |
| Inpeco SA | 510(k) number | 2020-04-07 | Class II | Software design | Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the cur | 71 systems | |
| Inpeco SA | 510(k) number | 2020-04-07 | Class II | Software design | In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from t | 97 systems | |
| Inpeco SA | 510(k) number | 2020-04-07 | Class II | Software design | In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from t | 61 systems | |
| Inpeco SA | 510(k) number | 2016-10-04 | Class II | Employee error | Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets. | 188 units | 2019-05-31 |
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.