Accelerator a3600 ACPRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07640172341001), received between Apr 23, 2019 and Sep 3, 2025 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

5 FDA recall records name this device's identifier, 5 still open.

28 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. 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 ↗

2. 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 ↗

3. 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 ↗

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-1559-2023 · 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-1560-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT A TUBE GOT STUCK IN THE STORAGE MODULE (SRM) WASTE CHUTE. AFTER HAVING REMOVED THE TUBE, THE AUTOMATION SYSTEM BEGAN TO NOTIFY TUBE DROP ERRORS. THE FIELD SERVICE ENGINEER (FSE) SUSPECTED THE SENSOR MAY HAVE BEEN CONTAMINATED. THE FSE CLEANED THE SENSOR (THAT IS LOCATED IN THE CHUTE), THEN OBSERVED TUBES GOING TO WASTE, IN ORDER TO VERIFY THE ISSUE WAS RESOLVED. DURING THIS TIME, ONE TUBE CAME DOWN, THE FOIL TOP BECAME LOOSE, AND THE CONTENTS OF THE TUBE SPLASHED THE FSE IN THE FACE. THE FSE CLEANED THE EYE WITH WATER AND CONTACTED A MEDICAL DOCTOR FOR ADVICE. THE FSE WAS ADVISED TO REMOVE CONTACT LENSES AND CLEAN WITH SALINE. ACCORDING TO THE INFORMATION AVAILABLE TO DATE, THE FSE PLANS TO GET TESTED FOR INFECTIOUS DISEASES.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953920 ↗
• InjuryMar 22, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE LABORATORY SUPERVISOR NOTIFIED THE FIELD SERVICE ENGINEER (FSE) ONSITE THAT, ON (B)(6) 2024 AROUND 6:30 PM, ONE OF THE TECHNICIANS HAD HIS FINGER JAMMED INSIDE THE ROBOT GRIPPER FINGERS OF THE CENTRIFUGE MODULE (CM), WHILE ATTEMPTING TO MANUALLY REMOVE A TUBE THAT WAS STUCK INSIDE THE GRIPPER DUE TO A BARCODE LABEL ISSUE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18958703 ↗
• MalfunctionNov 8, 2023Installation-Related Problem; Mechanical Jam; Insufficient Device Problem Information; Installation-Related Problem; Mechanical Jam; Insufficient Device Problem Information

  A CUSTOMER OUTSIDE US REPORTED A SAMPLE TUBE ID MISMATCH OCCURRED AT THE CENTRIFUGE MODULE WHICH CONNECTS THE AUTOMATION SYSTEM TRACK TO THE THIRD PARTY'S CENTRIFUGE. THE INVOLVED SAMPLE TUBES WERE A TUBE WHICH SHOULD HAVE BEEN DIVERTED INTO THE CENTRIFUGE MODULE BUT REMAINED ON THE MAIN TRACK (TUBE A) AND A SAMPLE TUBE LOADED INTO THE CENTRIFUGE (TUBE B). THE CARRIER WHICH WAS PHYSICALLY TRANSPORTING TUBE A WAS ERRONEOUSLY ASSOCIATED TO TUBE B. TUBE A WAS FLAGGED WITH ERROR SC06D "TUBE LOST IN PICK AND PLACE MODULE". THE REAL TUBE A WAS SENT TO THE ANALYZERS TO BE TESTED ACCORDING TO THE TEST ORDERS RECEIVED FOR TUBE B. THE TEST ORDERED FOR TUBE B SHOULD HAVE BEEN EXECUTED ON A CENTRIFUGED SAMPLE (SERUM OR PLASMA) WHILE TUBE A WAS STILL A WHOLE BLOOD SAMPLE. THE OBTAINED RESULTS WERE OUT OF NORMAL RANGE. THE SAMPLE TUBE WAS SORTED IN A RACK OF IOM#2. WHEN THE OPERATOR PERFORMED THE VISUAL CHECK ON THE SAMPLE BEFORE RE-RUN, HE BECAME AWARE OF THE SID MISMATCH ISSUE. HE BLOCKED THE RESULTS OBTAINED FROM TUBE A. WHEN THE REAL TUBE B WAS THEN RELEASED BY THE CENTRIFUGE MODULE, IT WAS FLAGGED AS DUPLICATE (SC00E) AND UNLOADED INTO THE PRIORITY OUTPUT RACK DEDICATED TO SAMPLE TUBES WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18090543 ↗
• InjuryOct 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CLIENT REPORTED THAT A LABORATORY OPERATOR WAS INJURED DURING TROUBLESHOOTING OF A "TIP CHAMBER JAM" ON THE ALIQUOTER MODULE. THE EMPLOYEE REMOVED THE LONG UPPER SIDE PANEL AND HIT HIM/HERSELF ON THE JAW CAUSING A DISLOCATION. THE EMPLOYEE VISITED THE EMERGENCY DEPARTMENT AND HAS BEEN OFF WORK SINCE THEN.

  Patient problems: Joint Dislocation

  MAUDE report 17955313 ↗
• InjuryJan 12, 2023Use of Device Problem; Use of Device Problem

  THE DISTRIBUTOR REPORTED A FIELD SERVICE ENGINEER SUFFERED A INJURY ON (B)(6) 2022 WHILE HE WAS WORKING ON THE STORAGE AND RETRIEVAL MODULE. HE HURT HIS LEFT SHOULDER WHILE HE WAS REMOVING AND LIFTING THE SRM SIDE COVER TO GAIN ACCESS TO THE SHELVES. THE DOCTOR ORDERED REHAB FROM ON (B)(6) 2022 TO ON (B)(6) 2022. THE FSE DISCONTINUED REHAB ON (B)(6) 2022 AND PERFORMED A MRI ON (B)(6) 2022. THE EVALUATION SHOWS A COMPLETE TEAR OFF OF TENDONS AND LARGE ROTATOR CUFF TEAR. THE FSE IS EVALUATING POSSIBLE TREATMENT OPTIONS SUGGESTED BY HIS DOCTOR.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 16144561 ↗
• MalfunctionOct 26, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER LOADED ON BULK INPUT MODULE (BIM) TWO SAMPLE TUBES WITH SAMPLE IDS (B)(6) ASSOCIATED TO PATIENT 1 AND (B)(6) ASSOCIATED TO PATIENT 2. THE BIM BARCODE READER READ (B)(6) AND ASSOCIATED THE OBTAINED RESULTS TO PATIENT 2. WHEN THE TUBE (B)(6) WAS LOADED ON THE BIM, IT WAS SENT TO THE RACK OUTPUT MODULE (ROM) WITHOUT RUNNING ANY ASSAY SINCE THE TESTS ORDERED FOR THIS TUBE WERE ALREADY EXECUTED AND THE TUBE WAS CONSIDERED COMPLETED BY THE AUTOMATION SOFTWARE. THE CUSTOMER REPORTED THAT THEY DISCOVERED THE ISSUE DUE TO THE DIFFERENCE IN THE TSH RESULTS. THE ERRONEOUS RESULTS WERE NOT SENT TO THE DOCTOR, NO TREATMENT WAS UNDERTAKEN WITH THE ERRONEOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671859 ↗
• MalfunctionJan 12, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A SAMPLE TUBE ID MISMATCH OCCURRED AT THE CENTRIFUGE MODULE WHICH CONNECTS THE AUTOMATION SYSTEM TRACK TO THE THIRD PARTY'S CENTRIFUGE. THE TUBE A HAS BEEN RELEASED BY THE CENTRIFUGE MODULE WITH THE SAMPLE ID OF ANOTHER TUBE PRESENT IN THE CENTRIFUGE (TUBE B). THE TUBE A HAS BEEN SENT TO THE ANALYZERS TO BE TESTED ACCORDING TO THE TEST ORDERS RECEIVED FOR TUBE B. WHEN THE REAL TUBE B HAS BEEN THEN RELEASED BY THE CENTRIFUGE MODULE, IT HAS BEEN FLAGGED AS DUPLICATE AND UNLOADED INTO THE PRIORITY OUTPUT RACK DEDICATED TO SAMPLE TUBES WITH ERROR MESSAGES AT THE INPUT OUTPUT MODULE TO BE MANUALLY MANAGED BY THE OPERATORS. THE OPERATOR RETRIEVED THE TUBE WRONGLY IDENTIFIED AS B AND NOTICED THAT IT WAS TUBE A. HE BLOCKED AND CORRECTED THE RESULTS OBTAINED FROM TUBE A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236130 ↗
• InjuryFeb 12, 2021Use of Device Problem; Use of Device Problem

  A LABORATORY TECHNICIAN INJURED HER HAND WHILE SHE WAS TRYING TO RETRIEVE SOME SAMPLE TUBES LOST AT THE STORAGE RETRIEVE MODULE AND ALLEGEDLY FALLEN UNDER THE AUTOMATION SYSTEM TRACK. THE INVOLVED TUBES WOULD BE CAPPED OR SEALED SO THEY DID NOT CAUSE ANY SAMPLE SPILLAGE. THE TECHNICIAN REMOVED THE PANEL AND SHE DID NOT PAUSE THE TRACK MOVEMENT. WHILE SHE WAS REACHING THE AREA TO CHECK FOR MISSING SAMPLE TUBES HER HAND BECAME LODGED AND SHE INJURED HER RIGHT INDEX FINGER (SKIN ABRASION AND NAIL DAMAGE). THE TECHNICIAN WAS WEARING GLOVES. AT THE ER, THEY CLEANED THE WOUND AND ADMINISTERED A TETANUS SHOT. THE XRAY RULED OUT ANY FRACTURE. THE INJURY IS MONITORED FOR INFECTION.

  Patient problems: Abrasion

  MAUDE report 11322547 ↗
• MalfunctionDec 10, 2020Component Misassembled; Component Misassembled

  THE EVENT OCCURRED DURING THE INSTALLATION OF THE AUTOMATION SYSTEM ACCELERATOR A3600 ACP.480. WHEN DISTRIBUTOR SERVICE PERSONNEL POWERED ON THE AUTOMATION SYSTEM FROM THE MAIN ELECTRICAL PANEL, THE POWER SUPPLIES OF SEVERAL MODULES OF THE AUTOMATION SYSTEM WERE DAMAGED. THE SERVICE PERSONNEL OBSERVED FLAMES FROM THE ELECTRICAL PANEL OF THE CENTRIFUGE MODULE #1 AND VISIBLE SMOKE FROM THE ELECTRICAL PANELS OF THE INPUT OUTPUT MODULE, STORAGE AND RETRIEVAL MODULE, CENTRIFUGE MODULE #2, AND (B)(4)INTERFACE MODULE. THE FIRE AUTO-EXTINGUISHED WITHOUT ANY INTERVENTION. NOBODY PRESENT IN THE LABORATORY WAS INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983931 ↗
• MalfunctionJan 10, 2020Use of Device Problem; Use of Device Problem

  A SAMPLE TUBE GOT STUCK INSIDE THE ROBOT GRIPPER OF THE RACK INPUT MODULE (RIM) WHICH IS AN AUTOMATION SYSTEM MODULE WHICH ALLOWS THE MOVEMENT OF SAMPLE TUBES FROM A RACK TO THE AUTOMATION SAMPLE CARRIERS. WHEN THE GRIPPER TRIED TO PLACE THE TUBE INTO THE CARRIER THE ERROR ON THE UP-DOWN ROBOT MOVEMENT WAS GENERATED AND THE MODULE STOPPED WORKING. THE ERROR RECOVERY REQUIRED THE INTERVENTION ON THE MODULE AND THE CUSTOMER CONTACTED THE SERVICE ASSISTANCE. THE INVOLVED TUBE WAS A SQUARE BASE TUBE WHICH IS NOT ALLOWED ON THE AUTOMATION SYSTEM: THE TUBE WAS ERRONEOUSLY PLACED INTO THE RACK LOADED IN THE RIM BY THE OPERATOR. THE FIELD SERVICE ENGINEER REMOVED THE SAFETY COVER AND TRIED TO PULL THE TUBE OUT OF THE GRIPPER. DOING SO, HE CUT HIS FINGER WITH THE GRIPPER FINGERS. HE WAS WEARING PPE, INCLUDING GLOVES. THE CUT DID NOT REQUIRE ANY MEDICAL TREATMENT. A BLOOD TEST WAS PERFORMED THE DAY AFTER THE INCIDENT: ALL TEST RESULTS WERE NEGATIVE. THE BLOOD TESTS WILL BE REPEATED AFTER 1 MONTH, 3 MONTHS, 6 MONTHS AND 12 MONTHS.

  Patient problems: Injury; Laceration(s); Unspecified Infection

  MAUDE report 9575273 ↗
• MalfunctionDec 30, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED A DISCREPANT SODIUM RESULT. ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER ON NOVEMBER 27TH THE SODIUM TEST WAS PERFORMED ON THE INVOLVED TUBE 3 TIMES: AT 7:14:23 ON ALINITY C AC01679 WITH THE RESULT NA = 142 MMOL/L AND AN AGAP >20 WHICH CAUSED AN AUTOMATIC RERUN. AT 7:32:24 ON ALINITY C AC01672 WITH THE RESULT NA = 118 MMOL/L, THE LABORATORY OPERATOR SAW THE DIFFERENCE IN THE 2 RESULTS AND REQUESTED THE SPECIMEN BE SENT TO THE INPUT OUTPUT MODULE. HE SAW A PIECE OF FOIL FLOATING ON TOP OF THE SPECIMEN, REMOVED IT AND ORDERED A RERUN. AT 7:50:16 ON THE FIRST ALINITY C AC01679 WITH THE RESULT NA = 142 MMOL/L. BESIDES SODIUM, FOR THE OTHER ANALYTES OF THE CHEM PANEL NO DISCREPANT RESULTS WERE FOUND. THE SECOND SODIUM RESULT (118 MMOL/L) WAS NOT REPORTED. THERE IS NO KNOWN IMPACT ON THE HEALTH CONDITIONS AND TREATMENT OF THE INVOLVED PATIENT. THE ALUMINUM FOIL IS USED BY INPECO SEALER MODULE TO SEAL UNCAPPED SAMPLE TUBES AND IT IS REMOVED BY THE INPECO DESEALER MODULE BEFORE TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9529451 ↗
• MalfunctionJun 18, 2019Overheating of Device; Overheating of Device

  THE CUSTOMER CONTACTED THE SERVICE ASSISTANCE FOR A CANOE ETHERNET COMMUNICATION OR CAN PROBLEM (SOFTWARE ISSUE). THE DISTRIBUTOR FSE CHECKED THE MODULES AND FOUND THAT THE TRACK CORNER OF THE AUTOMATION SYSTEM WAS NOT RESPONDING. HE FOUND EVIDENCE OF FIRE ON ONE OF TRACK CORNER CONTROL BOARDS AND ON THE CABLES ATTACHED TO THE BOARD. THE MALFUNCTION OCCURRED DURING THE INSTALLATION OF THE ACCELERATOR A3600 SYSTEM, SO THE EVENT DID NOT IMPACT ANY PATIENT. NOBODY IN THE LABORATORY NOTICED SMOKE NOR HAD TO INTERVENE TO EXTINGUISH THE POSSIBLE FIRE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FIRE AND THE SMOKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8707294 ↗
• MalfunctionApr 23, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED A MALFUNCTION OF THE ALIQUOTER MODULE INCLUDED IN THE ACCELERATOR A3600 AUTOMATION SYSTEM DUE TO A SHORT CIRCUIT INSIDE THE MODULE ELECTRICAL PANEL. THE SMALL ELECTRICAL FIRE CAUSED BY THE SHORT CIRCUIT AUTO-EXTINGUISHED WITHOUT THE INTERVENTION OF ANY LABORATORY TECHNICIANS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FIRE AND THE POSSIBLE SMOKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8539414 ↗

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-0595-2026 · Oct 30, 2025 · Open, Classified
  FlexLab (FLX); Version: FLX-217-10;
• Z-0107-2026 · Sep 3, 2025 · Open, Classified
  FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
• Z-0106-2026 · Sep 3, 2025 · Open, Classified
  FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
• Z-0560-2024 · Nov 3, 2023 · Open, Classified
  Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample
• Z-0087-2022 · Sep 10, 2021 · Open, Classified
  FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
• 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-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-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-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-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
• 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-2140-2020 · Apr 7, 2020 · Terminated
  FlexLab 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 Interface Modul

…and 13 more.