510(k) · Cleared
Recalled · Class II · 2025Flexlab 3.6, Accelerator A3600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inpeco S.P.A. · CEM Electrode, Ion Specific, Potassium
Cleared on Aug 31, 2012 as substantially equivalent to K093318 (Abbott Laboratories, 2010) after a 150-day review. Its family tree reaches back 6 generations to 1990. It has been recalled 33 times.
- Decided
- Aug 31, 2012
- Review
- 150 days
- Class
- Class II
- Product code
- CEM
- Recalls
- 33
- Predicates
- 1
Its longest line of descent runs back 6 generations to K902336 (1990). 10 ancestors in all, the oldest K872494 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 5 generations backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- 4 generations backK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- 3 generations backK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- 2 generations backK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · Recalled
- 1 generation backK093318 Accelerator ApsAbbott Laboratories · 2010 · Recalled
- This deviceK121012 Flexlab 3.6, Accelerator A3600Inpeco S.P.A. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −5 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| −4 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −3 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| −2 | K082638 | Advia Centaur System with Streamlab Analytical Workcell | Siemens Healthcare Diagnostics, Inc. | 2009 | 3 |
| −1 | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | 2 |
| 0 (this device) | K121012 | Flexlab 3.6, Accelerator A3600 | Inpeco S.P.A. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093318 | Accelerator ApsSummary page 2…e 2 === Identification of Predicate Device: Predicate Instrument or 510(k) Number Product Code Assay Al'S Accelerator K093318 JQP Description: The following is a brief description of the FlexLab 3.6 system. The FlexLab 3.6 Automa… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2025 | Class II | Z-0596-2026 | 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… |
| Oct 30, 2025 | Class II | Z-0595-2026 | 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… |
| Sep 3, 2025 | Class II | Z-0106-2026 | 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… |
| Sep 3, 2025 | Class II | Z-0107-2026 | 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… |
| Nov 3, 2023 | Class II | Z-0560-2024 | 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. |
| Mar 10, 2023 | Class II | Z-1561-2023 | 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… |
| Mar 10, 2023 | Class II | Z-1559-2023 | 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… |
| Mar 10, 2023 | Class II | Z-1563-2023 | 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… |
| Mar 10, 2023 | Class II | Z-1560-2023 | 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… |
| Mar 10, 2023 | Class II | Z-1562-2023 | 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… |
| Sep 10, 2021 | Class II | Z-0087-2022 | 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. |
| Aug 7, 2020 | Class II | Z-2975-2020 | 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 |
| Aug 7, 2020 | Class II | Z-2974-2020 | 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 |
| Aug 7, 2020 | Class II | Z-2973-2020 | 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 |
| Jul 14, 2020 | Class II | Z-0433-2021 | 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… |
| Jul 14, 2020 | Class II | Z-0434-2021 | 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… |
| Jul 14, 2020 | Class II | Z-0432-2021 | 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… |
| Apr 7, 2020 | Class II | Z-2141-2020 | Software design | 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. This problem can occur only when one of… |
| Apr 7, 2020 | Class II | Z-2140-2020 | Software design | 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. This problem can occur only when one of… |
| Apr 7, 2020 | Class II | Z-1889-2020 | Software design (manufacturing process) | The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge. |
| Apr 7, 2020 | Class II | Z-2003-2020 | 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. |
| Apr 7, 2020 | Class II | Z-2198-2020 | 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… |
| Apr 7, 2020 | Class II | Z-1888-2020 | Software design (manufacturing process) | The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge. |
| Apr 7, 2020 | Class II | Z-2199-2020 | 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… |
| Apr 7, 2020 | Class II | Z-2142-2020 | Software design | 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. This problem can occur only when one of… |
| Apr 7, 2020 | Class II | Z-1887-2020 | Software design (manufacturing process) | The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge. |
| Apr 7, 2020 | Class II | Z-2004-2020 | 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. |
| Apr 7, 2020 | Class II | Z-2200-2020 | 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… |
| Apr 7, 2020 | Class II | Z-2114-2020 | 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. |
| Apr 7, 2020 | Class II | Z-2115-2020 | 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. |
| Aug 24, 2018 | Class II | Z-0361-2019 | Under Investigation by firm | 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 specify that: 1) the risk of a… |
| Feb 13, 2018 | Class II | Z-1798-2018 | Device Design | 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 | 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. |
The 5 latest of 33 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- 6 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K093318.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2007high 4 (2012) · low 0 (2008)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
2007high 195 (2010) · low 74 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
2007high 12 (2010) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
2007high 245 (2008) · low 4 (2014)2025
MAUDE reports naming product code CEM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121012: Flexlab 3.6, Accelerator A3600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121012
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026