# K121012: Flexlab 3.6, Accelerator A3600

- Pathway: 510(k) (Traditional)
- Applicant: Inpeco S.P.A.
- Decided: Aug 31, 2012 after 150 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: 33 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902336 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093318: Accelerator Aps, Abbott Laboratories (2010) Summary page 2.

## Recalls of this device
- Oct 30, 2025 · Class II · Z-0596-2026: 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 op
- Oct 30, 2025 · Class II · Z-0595-2026: 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 op
- Sep 3, 2025 · Class II · Z-0106-2026: 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 effec
- Sep 3, 2025 · Class II · Z-0107-2026: 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 eff
- Nov 3, 2023 · Class II · Z-0560-2024: Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
- Mar 10, 2023 · Class II · Z-1561-2023: 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 ca
- Mar 10, 2023 · Class II · Z-1559-2023: 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 ca
- Mar 10, 2023 · Class II · Z-1563-2023: 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 ca
- Mar 10, 2023 · Class II · Z-1560-2023: 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 ca
- Mar 10, 2023 · Class II · Z-1562-2023: 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 ca
- Sep 10, 2021 · Class II · Z-0087-2022: 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 in
- Aug 7, 2020 · Class II · Z-2975-2020: 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
- Aug 7, 2020 · Class II · Z-2974-2020: 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
- Aug 7, 2020 · Class II · Z-2973-2020: 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
- Jul 14, 2020 · Class II · Z-0433-2021: 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 T
- Jul 14, 2020 · Class II · Z-0434-2021: 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 T
- Jul 14, 2020 · Class II · Z-0432-2021: 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 T
- Apr 7, 2020 · Class II · Z-2141-2020: The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. Th
- Apr 7, 2020 · Class II · Z-2140-2020: The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. Th
- Apr 7, 2020 · Class II · Z-1889-2020: The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
- Apr 7, 2020 · Class II · Z-2003-2020: When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
- Apr 7, 2020 · Class II · Z-2198-2020: 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 generat
- Apr 7, 2020 · Class II · Z-1888-2020: The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
- Apr 7, 2020 · Class II · Z-2199-2020: 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 bac
- Apr 7, 2020 · Class II · Z-2142-2020: The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. Th
- Apr 7, 2020 · Class II · Z-1887-2020: The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
- Apr 7, 2020 · Class II · Z-2004-2020: When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
- Apr 7, 2020 · Class II · Z-2200-2020: 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 bac
- Apr 7, 2020 · Class II · Z-2114-2020: 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 desi
- Apr 7, 2020 · Class II · Z-2115-2020: 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 desi
- Aug 24, 2018 · Class II · Z-0361-2019: The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to
- Feb 13, 2018 · Class II · Z-1798-2018: Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
- Oct 4, 2016 · Class II · Z-0587-2017: Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets.

## Indications for use
The FlexLab 3.6 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 analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that performs a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

Source page: https://510kreport.com/device/K121012
Methodology: https://510kreport.com/methodology