Flexlab 3.6, Accelerator A3600

• • Ongoing Z-0595-2026 FDA Class II ·initiated 30 Oct 2025

  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 error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.

• • Ongoing Z-0596-2026 FDA Class II ·initiated 30 Oct 2025

  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 error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes

• • Ongoing Z-0107-2026 FDA Class II ·initiated 3 Sep 2025

  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 cause an increase in erroneous results or a delay in patient results.

• • Ongoing Z-0106-2026 FDA Class II ·initiated 3 Sep 2025

  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 cause an increase in erroneous results or a delay in patient results.

• • Ongoing Z-0560-2024 FDA Class II ·initiated 3 Nov 2023

  Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.

• 5 recalls, same reason

  • Ongoing Z-1562-2023 FDA Class II ·initiated 10 Mar 2023
  • Ongoing Z-1563-2023 FDA Class II ·initiated 10 Mar 2023
  • Ongoing Z-1561-2023 FDA Class II ·initiated 10 Mar 2023
  • Ongoing Z-1559-2023 FDA Class II ·initiated 10 Mar 2023
  • Ongoing Z-1560-2023 FDA Class II ·initiated 10 Mar 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 can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the test orders not performed yet on Tube B. Inpeco has released a Technical Service Bulletin with the procedure to correctly update the firmware. The firmware upgrade will be performed by Field Service Engineers. A CAPA (Corrective Action Preventive Action) has been opened to deeply investigate the root cause and identify possible process lack in order to avoid reoccurrences.

• • Ongoing Z-0087-2022 FDA Class II ·initiated 10 Sep 2021

  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.

• 3 recalls, same reason

  • Ongoing Z-1889-2020 FDA Class II ·initiated 7 Apr 2020 ·on shared 510(k) K121012
  • Ongoing Z-1888-2020 FDA Class II ·initiated 7 Apr 2020 ·on shared 510(k) K121012
  • Ongoing Z-1887-2020 FDA Class II ·initiated 7 Apr 2020 ·on shared 510(k) K121012

  The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

• • Ongoing Z-2198-2020 FDA Class II ·initiated 7 Apr 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 generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.

• 2 recalls, same reason

  • Ongoing Z-2199-2020 FDA Class II ·initiated 7 Apr 2020
  • Ongoing Z-2200-2020 FDA Class II ·initiated 7 Apr 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 back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.

• 3 recalls, same reason

  • Terminated Z-2975-2020 FDA Class II ·initiated 7 Aug 2020
  • Terminated Z-2974-2020 FDA Class II ·initiated 7 Aug 2020
  • Terminated Z-2973-2020 FDA Class II ·initiated 7 Aug 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

• 3 recalls, same reason

  • Terminated Z-0432-2021 FDA Class II ·initiated 14 Jul 2020
  • Terminated Z-0434-2021 FDA Class II ·initiated 14 Jul 2020
  • Terminated Z-0433-2021 FDA Class II ·initiated 14 Jul 2020

  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 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.

• 2 recalls, same reason

  • Terminated Z-2115-2020 FDA Class II ·initiated 7 Apr 2020 ·on shared 510(k) K121012
  • Terminated Z-2114-2020 FDA Class II ·initiated 7 Apr 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 design.

• 2 recalls, same reason

  • Terminated Z-2003-2020 FDA Class II ·initiated 7 Apr 2020
  • Terminated Z-2004-2020 FDA Class II ·initiated 7 Apr 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.

• 3 recalls, same reason

  • Terminated Z-2141-2020 FDA Class II ·initiated 7 Apr 2020 ·on shared 510(k) K121012
  • Terminated Z-2140-2020 FDA Class II ·initiated 7 Apr 2020 ·on shared 510(k) K121012
  • Terminated Z-2142-2020 FDA Class II ·initiated 7 Apr 2020 ·on shared 510(k) K121012

  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 these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.

• • Terminated Z-0361-2019 FDA Class II ·initiated 24 Aug 2018 ·on shared 510(k) K121012

  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 pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has been increased to 200 mm (7.87") from the transport mechanisms. Any person with a pacemaker must not get closer than this distance from the modules axes.

• • Terminated Z-1798-2018 FDA Class II ·initiated 13 Feb 2018 ·on shared 510(k) K121012

  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.

• • Terminated Z-0587-2017 FDA Class II ·initiated 4 Oct 2016

  Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K121012 ↗

FDA Product Code

CEM

Device Class

Class II

Regulation

21 CFR Part 862.1600

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent