FlexLab FLXRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07640172340004), received between Nov 29, 2019 and Aug 6, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 reports).

8 FDA recall records name this device's identifier, 8 still open.

25 other recalls cover devices cleared under the same FDA submission (K121012); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 30, 2025Open, Classified

   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.

   Z-0595-2026 · Root cause: Device Design · FDA record ↗

2. Sep 3, 2025Open, Classified

   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.

   Z-0106-2026 · Root cause: No Marketing Application · FDA record ↗

3. Nov 3, 2023Open, Classified

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

   Z-0560-2024 · Root cause: Software Design Change · FDA record ↗

4. Mar 10, 2023Open, Classified

   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.

   Z-1563-2023 · Root cause: Under Investigation by firm · FDA record ↗

5. Mar 10, 2023Open, Classified

   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.

   Z-1559-2023 · Root cause: Under Investigation by firm · FDA record ↗

6. Mar 10, 2023Open, Classified

   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.

   Z-1562-2023 · Root cause: Under Investigation by firm · FDA record ↗

7. Mar 10, 2023Open, Classified

   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.

   Z-1561-2023 · Root cause: Under Investigation by firm · FDA record ↗

8. Mar 10, 2023Open, Classified

   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.

   Z-1560-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50156275 ↗
• MalfunctionSep 4, 2025Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED ANOTHER OCCURRENCE OF THE EVENT DESCRIBED IN MDR 3010825766-2025-00003 IN THE SAME LABORATORY. THE ALIQUOTER MODULE (ALX, #3) CAUSED THE MISMATCH OF MORE THAN 200 TUBES BETWEEN DAUGHTER AND MOTHER TUBES. THE IMPACTED SAMPLE TUBES HAD TO BE MANUALLY RETRIEVED BY THE OPERATORS. THE MISMATCH PROBABLY STARTED AFTER THE ERROR "M34E0 - TUBE LABELED ORIENTATION VERIFICATION ACTIVATED ERROR" AT AROUND 5:11AM IN THE NIGHT OF THE (B)(6) 2025. ACCORDING TO THE LABORATORY WORKFLOW, THE MOTHER TUBES ARE TESTED BEFORE BEING SENT TO THE ALIQUOTER MODULE. THE ALIQUOT SAMPLE TUBES CAN BE SORTED AT THE INPUT OUTPUT MODULE (IOX) TO PERFORM PCR TESTS OUTSIDE THE AUTOMATION SYSTEM OR SENT TO THE TESTED ON THE COBAS 8000 INSTRUMENT. IN THE FIRST CASE, THE OPERATOR MAY BECOME AWARE OF THE MISMATCH WHEN HE FINDS IN THE SORTING RACK EITHER A SAMPLE TUBE WITH A TEST NAME PRINTED ON THE LABEL DIFFERENT FROM THE TEST NAME WRITTEN ON THE IOX DISPLAY BAR OR A SAMPLE TUBE WITH AN UNEXPECTED SID. IF THE MISMATCH IS NOT NOTICED, THE EVENT MAY LEAD TO INCORRECT RESULTS. THE CUSTOMER DID NOT COMMUNICATE ANY REAL CLINICAL IMPACT ON THE INVOLVED PATIENTS. IN THE SECOND CASE, DUE TO THE ANALYZER'S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961997 ↗
• MalfunctionJul 25, 2025Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT SOME ALIQUOT SAMPLE TUBES WERE NOT SORTED INTO THE CORRECT DESTINATION LANES. INPECO SERVICE PERSONNEL PRESENT ON SITE INVESTIGATED SOME OF THE INVOLVED SIDS. THEY NOTICED THAT SIDS PHYSICALLY SORTED TO INPUT OUTPUT MODULE (IOX) STILL APPEARED AS PRESENT ON THE TRACK ACCORDING TO SMS/DMS. WHEN THEY REQUESTED THE DELIVERY OF THESE SIDS, THEY RECEIVED SAMPLE TUBES WITH A SID PRINTED ON THE LABEL DIFFERENT FROM THE EXPECTED ONE. THE IMPACTED ALIQUOT SAMPLE TUBES WERE GENERATED BY THE ALIQUOTER MODULE (ALX, #2), IN ALL CASES THE MISMATCHED SAMPLE TUBES WERE RELEASED CONSECUTIVELY BY THE ALIQUOTER MODULE. THE FSES TOOK THE ALIQUOTER MODULE OFFLINE AND USED THE GRAPHIC INTERFACE TO INSPECT THE CARRIERS AND SIDS CURRENTLY PRESENT IN THE BUFFER LANE OF THE MODULE. THEY CONFIRMED THAT, ACCORDING TO THE INFORMATION DISPLAYED ON THE GRAPHIC INTERFACE, THE DAUGHTER SID WAS IN THE WRONG POSITION: NOT AT THE DISPENSING GATE, BUT AT THE PREVIOUS POSITION. BASED ON THE HYPOTHESIS THAT THE MISMATCH WAS TRIGGERED BY AN IMPROPER RECOVERY FROM ERROR M34EE - NO TUBE ON PICK AREA, THE FSES COMPILED A LIST OF APPROXIMATELY 300 IMPACTED SIDS, WHICH HAVE BEEN RECALLED FOR MANUAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607035 ↗
• MalfunctionFeb 21, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT APPROXIMATELY 5000 TUBES WERE PROCESSED ON THE ALIQUOTER MODULE #4 BETWEEN JAN. 12TH AND 24TH, MOST OF THEM WITHOUT A ERROR NOTIFICATION THE CUSTOMER REPORTED THAT WATER FROM PIPETTOR CIRCUIT OF THE ALIQUOTER MODULE WAS ALIQUOTED INTO THE DAUGHTER TUBES. ON JAN 14TH THE CUSTOMER SERVICE ENGINEER (CSE) THAT INVESTIGATED THE ISSUE, REPLACED SOME COMPONENTS OF THE ALIQUOTER MODULE #4. THE CUSTOMER REPORTED AGAIN THAT WATER WAS ALIQUOTED INTO THE DAUGHTER TUBES WITHOUT ERROR NOTIFICATION. ON JAN. 24TH, ACCORDING TO THE DISTRIBUTOR'S INVESTIGATION IT WAS DETERMINED THAT THE TUBING JUNCTION AT THE PIPETTOR VALVE WAS LOOSE, AND THIS WAS LIKELY THE CAUSE OF WATER MAKING INTO THE PIPETTOR TIP AND INTO SAMPLE TUBES. THE TUBE WAS REPLACED ALONG WITH THE VALVE AND PUMP AND INSPECTED FOR PROPER CONNECTION. PREVENTATIVE MAINTENANCE AND PUMP CALIBRATION PROCEDURES WERE PERFORMED. ON JAN. 28TH ADDITIONAL TESTING WERE PERFORMED BY THE CSE TO CHECK THAT THE ALIQUOTER MODULE#4 WORKS AS EXPECTED WITHOUT DILUTING THE DAUGHTER TUBES. ALIQUOTER MODULE #4 RETURNED TO ROUTINE OPERATION ON FEB. 4TH. ACCORDING TO THE PRELIMINARY INFORMATION PROVIDED, THE RESULTS OF THE DILUTED ALIQ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21430293 ↗
• MalfunctionAug 8, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT THE ASPIRATION OF THE ROBOT OF THE ALIQUOTER MODULE OF FLEXLAB IS QUITE ABRUPT, AND CAUSES TURBULENCE IN THE SAMPLE TUBE.THE CITRATE TUBES FOR THE COAGULATION DON'T HAVE A GEL LAYER; THEREFORE THE CENTRIFUGED CELLS CAN BE RESUSPENDED IF THE ASPIRATION FORCES ARE TOO STRONG.THE CONSEQUENCE IS THE CREATION OF ALIQUOTS CONTAINING CORPUSCOLAR PARTICLES, THAT COULD GIVE INCORRECT RESULTS, AS THE CELLS ARE MEASURED ALONG WITH THE PLASMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19936807 ↗
• MalfunctionMar 6, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A US CUSTOMER REPORTED THAT AN ERRATIC RESULT WAS OBTAINED FROM AN ALIQUOTED TUBE GENERATED ON THE FLEXLAB AUTOMATION SYSTEM. THE MOTHER TUBE WAS LOADED ON THE AUTOMATION SYSTEM: THE VOLUME WAS EVALUATED SUFFICIENT, SO THE TUBE WAS DIVERTED TO THE ALIQUOTER MODULE (ALQ). A SINGLE DAUGHTER TUBE WAS GENERATED WITHOUT ANY ERROR MESSAGE. THE DAUGHTER TUBE WAS RECAPPED AND UNLOADED TO BE TESTED FOR THE ANTINUCLEAR ANTIBODY (ANA) ASSAY OFF-TRACK. A NEGATIVE RESULT WAS OBTAINED. THE RESULT WAS CHALLENGED BY THE DOCTOR WHO ORDERED A RERUN ON THE MOTHER TUBE AND ON ANOTHER PRIMARY TUBE OF THE SAME PATIENT. BOTH THE RESULTS WERE POSITIVE. THE CUSTOMER NOTED THE COLOR OF THE SERUM IN THE DAUGHTER TUBE SEEMED CLEAR AND SUSPECTED IT MAY HAVE BEEN DILUTED WITH THE WATER OF THE ALQ TUBE SYSTEM WITHOUT ANY WARNING. BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER, NO HARM CAME TO THE PATIENT AND NO DELAY IN TREATMENT OCCURRED. THE CUSTOMER ALSO REQUESTED A CHECK OF THE SAMPLE TUBES MANAGED BY THE ALIQUOTER MODULE BEFORE AND AFTER THE IMPACTED MOTHER TUBE AND NO PROBLEMS WITH RESULTS WERE IDENTIFIED FOR THOSE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844203 ↗
• MalfunctionSep 8, 2023Mechanical Problem; Mechanical Problem

  SAMPLE RESIDUES HAVE BEEN FOUND ON SEVERAL TRACK BYPASS MODULES (TBM) OF FLEXLAB AS RESULTS OF SAMPLE SPILLAGE. THE TBM IS A SECTION OF TRACK WHERE THE CARRIERS WHICH TRANSPORT THE SAMPLE TUBES ARE DIVERTED TO REACH MORE QUICKLY THE NEEDED MODULES/INTERFACE MODULES. THE POSSIBLE RISK ASSOCIATED TO THIS ISSUE IS THE CROSS-CONTAMINATION OF ANOTHER UNCAPPED TUBE IN THE AREA WHERE THE TUBE SPILLED. THE CUSTOMER REPORTED A CASE OF SAMPLE TUBE POTENTIALLY CONTAMINATED AT THE TBM#14 WITH CONSEQUENT INCORRECT RESULTS. ACCORDING TO THE CUSTOMER, THE SAMPLE TUBE WITH ID (B)(6) WAS TESTED FOR THCG (HUMAN CHORIONIC GONADOTROPIN), AND THE RESULT 111.10 WAS REPORTED AND QUESTIONED BY THE PHYSICIAN SINCE IT WAS NOT CONSISTENT WITH PATIENT HEALTH CONDITIONS. THE CUSTOMER USED ANOTHER SAMPLE TUBE OF THE SAME PATIENT TO REPEAT THE ANALYSIS ON ANOTHER SIEMENS ATELLICA ANALYZER, RESULTING IN <2. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17708769 ↗
• InjuryFeb 22, 2023Use of Device Problem; Use of Device Problem

  IN OCTOBER 2022, THE LABORATORY FOUND THROUGH WIPE TESTS CHLAMYDIA AND GONOCOCCAL CONTAMINATION ON THE GRIPPERS OF THE INTERFACE MODULES WHICH CONNECT THE FLEXLAB AUTOMATION SYSTEM WITH PANTHER (THIRD PARTY ANALYZER). THE CUSTOMER SUSPECTED THAT THE SAMPLE TUBES PROCESSED BY THE PANTHER CONNECTED TO THE AUTOMATION SYSTEM MAY BE CROSS CONTAMINATED AND THE TEST RESULTS MAY BE ALTERED. THE AUTOMATION SYSTEM INTERFACE MODULE WITH PANTHER HAS A ROBOT TO PICK UP THE SAMPLE TUBES FROM THE CARRIERS AND PLACE THEM ON THE SHUTTLE OF THE ANALYZER TO BE TESTED. IN THIS LABORATORY THE PANTHER ANALYZERS PROCESS ONLY CAPPED APTIMA TUBES THROUGH CAP PIERCING. INFORMATION RECEIVED FROM THE FIELD: "ALL DATA GENERATED BY THE PANTHER SYSTEMS FOR CT AND GO IN THE PERIOD JUNE-OCTOBER HAS BEEN EXAMINED BY THE LABORATORY AND IT HAS BEEN DETERMINED THAT IN 21 RESULTS OF GGD APPLICANTS IT CANNOT BE STATED WITH CERTAINTY THAT THESE ARE REALLY POSITIVE. THE GGD HAS BEEN ASKED TO LOOK AT THE CLINICAL EXAMINATION. IN 3 APPLICATIONS IT WAS STATED THAT THE CLINIC CORRESPONDS TO STD AND THE RELEVANT GGD HAS NOT TAKEN ANY FURTHER ACTION. ANOTHER GGD HAD 18 RESULTS THAT WERE POSSIBLY FALSE POSITIVES. FROM THE CLINIC

  Patient problems: Insufficient Information

  MAUDE report 16415876 ↗
• MalfunctionJan 20, 2022Mechanical Problem; Mechanical Problem

  CASES OF SAMPLE SPILLAGE HAVE BEEN REPORTED FROM THE FIELD AT THE ENTRY OF SOME INTERNAL U-TURN MODULES. THIS MODULE PROVIDES A SHORT WAY FOR CARRIERS TO REACH THEIR DESTINATION ON THE AUTOMATION SYSTEM BY DIVERTING THEM TO A U-SHAPED LANE CONNECTING A PORTION OF TRACK WITH OPPOSITE FLOW DIRECTION. THE SAMPLE SPILLAGE MAY CAUSE CROSS CONTAMINATION IF THE SAMPLE DROPS FALL INTO ANOTHER UNCAPPED SAMPLE TUBE PRESENT IN THE QUEUE OR IN THE MAIN LANE. SAMPLE RESIDUES HAVE BEEN FOUND ON THE TRACK PROFILE. THE INVESTIGATION PERFORMED UP TO NOW DID NOT PROVIDE ANY EVIDENCE OF CROSS CONTAMINATION. NO DISCREPANT TEST RESULTS POTENTIALLY CAUSED BY SAMPLE CROSS CONTAMINATION HAVE BEEN IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309003 ↗
• MalfunctionDec 10, 2021Mechanical Problem; Mechanical Problem

  SAMPLE RESIDUES HAVE BEEN FOUND AT THE EXIT OF THE WIDE BELT CARRIER BUFFER MODULES (WBB) WHERE THE SAMPLE TUBES PREVIOUSLY PARKED IN THE MODULE BUFFER RETURNED ON THE PIT LANE. THE WIDE BELT CARRIER BUFFER MODULE IS A SAMPLE CARRIERS COLLECTOR THAT PROVIDES THE CAPABILITY TO RELIEVE THE TRACK WORKLOAD. THE SAMPLE SPILLAGE MAY HAVE CAUSED THE CONTAMINATION OF OTHER UNCAPPED SAMPLE TUBES PRESENT IN THE AREA. SO FAR NO CASES OF ACTUAL CROSS CONTAMINATION HAVE BEEN IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974604 ↗
• MalfunctionMar 5, 2021Mechanical Problem; Mechanical Problem

  A CASE OF SAMPLE SPILLAGE HAS BEEN REPORTED AT THE LOAD GATE OF THE BULK INPUT MODULE (BIM). THE BIM IS AN INPUT MODULE WHICH ALLOWS TO LOAD DIRECTLY ON THE TRACK CARRIERS CAPPED SAMPLE TUBES THROUGH TWO LANES DESIGNED FOR TUBES WITH DIAMETER 16MM AND TUBES WITH DIAMETER 13MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11421952 ↗
• MalfunctionFeb 26, 2021Mechanical Problem; Mechanical Problem

  SEVERAL CASES OF SAMPLE SPILLAGE HAVE BEEN REPORTED WHEN CARRIERS WITH UNCAPPED TUBES ARE DIVERTED INTO THE TRACK BYPASS MODULES (TBM), WHEN THE CARRIERS PASS FROM BELT TO TBM DISK AND AT THE MODULE EXIT IN CASE OF COLLISION WITH THE CARRIERS COMING FROM THE SECONDARY LANE. THE TRACK BYPASS MODULE IS A 90-DEGREE BEND SECTION OF THE TRACK WHICH PROVIDES A SHORT WAY FOR SAMPLE TUBES TO REACH THEIR ANALYZER OR AUTOMATION MODULE DESTINATION. THE TWO PORTIONS OF TBM TRACK ARE LINKED BY A ROTATING DISK. THE SAMPLE SPILLAGE MAY CAUSE CROSS CONTAMINATION IF THE SAMPLE DROPS FALL INTO ANOTHER UNCAPPED SAMPLE TUBE PRESENT IN THE AREA. SAMPLE RESIDUES HAVE BEEN FOUND ON THE TRACK PROFILE, THE INVESTIGATION PERFORMED UP TO NOW DID NOT PROVIDE ANY EVIDENCE OF CROSS CONTAMINATION. NO DISCREPANT TEST RESULTS POTENTIALLY CAUSED BY SAMPLE CROSS CONTAMINATION HAVE BEEN IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386370 ↗
• MalfunctionFeb 26, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED CASES OF SAMPLE SPILLAGE AT THE OVER UNDER PASS MODULES (OUM). SPECIFICALLY, SAMPLE RESIDUES HAVE BEEN FOUND AT THE ENTRY WHEN CARRIERS ARE DIVERTED INTO THE MODULE SECONDARY LANE, AT THE CORNER OF THE SECONDARY LANE AND AT THE EXIT OF THE MODULE. THE OUM CONNECTS TWO AREAS OF THE LABORATORY THROUGH AN OVERPASS TRACK PORTION. THE SAMPLE SPILLAGE MAY CAUSE CROSS CONTAMINATION IF THE SAMPLE DROPS FALL INTO ANOTHER UNCAPPED SAMPLE TUBE PRESENT IN THE AREA. SAMPLE RESIDUES HAVE BEEN FOUND ON THE TRACK PROFILE, THE INVESTIGATION PERFORMED UP TO NOW DID NOT PROVIDE ANY EVIDENCE OF CROSS CONTAMINATION. NO DISCREPANT TEST RESULTS POTENTIALLY CAUSED BY SAMPLE CROSS CONTAMINATION HAVE BEEN IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386219 ↗
• MalfunctionFeb 26, 2021Mechanical Problem; Mechanical Problem

  SEVERAL CASES OF SAMPLE SPILLAGE HAVE BEEN REPORTED FROM THE FIELD AT THE EXIT OF TWO INTERNAL U-TURN MODULES. THIS MODULE PROVIDES A SHORT WAY FOR CARRIERS TO REACH THEIR DESTINATION ON THE AUTOMATION SYSTEM BY DIVERTING THEM TO A U-SHAPED LANE CONNECTING A PORTION OF TRACK WITH OPPOSITE FLOW DIRECTION. THE SAMPLE SPILLAGE MAY CAUSE CROSS CONTAMINATION IF THE SAMPLE DROPS FALL INTO ANOTHER UNCAPPED SAMPLE TUBE PRESENT IN THE AREA. SAMPLE RESIDUES HAVE BEEN FOUND ON THE TRACK PROFILE, THE INVESTIGATION PERFORMED UP TO NOW DID NOT PROVIDE ANY EVIDENCE OF REAL CROSS CONTAMINATION. NO DISCREPANT TEST RESULTS POTENTIALLY CAUSED BY SAMPLE CROSS CONTAMINATION HAVE BEEN IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385950 ↗
• MalfunctionOct 23, 2020Mechanical Problem; Mechanical Problem

  CASES OF SAMPLE SPILLAGE HAVE BEEN OBSERVED AT THE TRACK BYPASS MODULES (TBM). THE TBM IS A SECTION OF TRACK WHERE THE CARRIERS THAT TRANSPORT THE SAMPLE TUBES ARE DIVERTED TO REACH THE NEEDED MODULES/INTERFACE MODULES MORE QUICKLY. THE POSSIBLE RISK ASSOCIATED TO THIS ISSUE IS THE CROSS-CONTAMINATION OF ANOTHER UNCAPPED TUBE IN THE AREA WHERE THE TUBE SPILLED. THE CUSTOMER DID NOT REPORT ANY ACTUAL CASE OF TEST RESULTS POTENTIALLY IMPACTED BY A POSSIBLE CROSS-CONTAMINATION. THE USERS AND THE SERVICE PERSONNEL DID NOT COME IN CONTACT WITH THE SPILLAGE THANKS TO THE TRACK COVERS. THE TRACK CLEANING WAS DONE WITH PPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10726701 ↗
• InjuryFeb 20, 2020Use of Device Problem; Use of Device Problem

  AN INPECO FSE RECEIVED AN ELECTRICAL SHOCK WHILE HE WAS WORKING ON THE AUTOMATION SYSTEM, SPECIFICALLY HIS RIGHT HAND TOUCHED A LIVE 240V WIRE WHILE HE WAS REPLACING THE CIRCUIT BREAKER OF A DISTRIBUTION BOARD OF THE HIGH VOLUME STORAGE.

  Patient problems: Electric Shock

  MAUDE report 9731889 ↗
• MalfunctionNov 29, 2019Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED SEVERAL CASES OF SAMPLE SPILLAGE ALONG THE TRACK. SAMPLE RESIDUES HAVE BEEN FOUND ON THE TRACK BELT, TRACK PROFILE AND ON THE SAFETY COVERS. THE EVENT COULD LEAD TO THE CROSS-CONTAMINATION OF THE OTHER UNCAPPED TUBES THAT MAY BE PRESENT IN THE AREA. ACCORDING TO THE INFORMATION PROVIDED FROM THE FIELD, NO DISCREPANT RESULTS HAVE BEEN REPORTED AND SO FAR PATIENT TESTING HAS NOT BEEN AFFECTED. THE INVESTIGATION IS STILL ONGOING TO DETERMINE THE ROOT CAUSE OF THE SAMPLE SPILLAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9391930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121012. One submission often covers many models, so check the product and lot details in each record.

• Z-0596-2026 · Oct 30, 2025 · Open, Classified
  FlexLab (FLX); Version: FLX-217-40;
• Z-0107-2026 · Sep 3, 2025 · Open, Classified
  FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
• Z-0087-2022 · Sep 10, 2021 · Open, Classified
  FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
• Z-2973-2020 · Aug 7, 2020 · Terminated
  FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Produc
• Z-2975-2020 · Aug 7, 2020 · Terminated
  Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Syst
• Z-2974-2020 · Aug 7, 2020 · Terminated
  Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Syst
• Z-0434-2021 · Jul 14, 2020 · Terminated
  Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Ana
• Z-0433-2021 · Jul 14, 2020 · Terminated
  Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to auto
• Z-0432-2021 · Jul 14, 2020 · Terminated
  FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate
• Z-2115-2020 · Apr 7, 2020 · Terminated
  Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliqu
• Z-2004-2020 · Apr 7, 2020 · Terminated
  Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designe
• Z-2114-2020 · Apr 7, 2020 · Terminated
  FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Modul
• Z-2141-2020 · Apr 7, 2020 · Terminated
  Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Inter
• Z-2198-2020 · Apr 7, 2020 · Open, Classified
  FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
• Z-1887-2020 · Apr 7, 2020 · Open, Classified
  Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

…and 10 more.