AptioTM Automation 10713760Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00630414596754), received between Jul 7, 2017 and May 12, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 16, 2023Open, Classified

   A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a few milliseconds timeframe of each other: - The SRM module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the SRM module buffer - There is divert gate malfunction and a narrow timing window Only in this specific scenario, Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without a unique error message being generated. 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 pending test orders (not yet performed) on Tube B.

   Z-2091-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 6, 2021Open, Classified

   The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.

   Z-0193-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Sparking; Power Problem; Sparking; Power Problem

  THE CUSTOMER REPORTED THE OBSERVATION OF SMOKE AND FLAMES AT THE LOCATION ON THE TRACK THAT HOUSED THE POWER CABLE FOR THE CENTRIFUGE MODULE. THE POWER TO THE CENTRIFUGE MODULE WAS TURNED OFF AND THE CUSTOMER USED A FIRE EXTINGUISHER TO EXTINGUISH THE FLAMES. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR REQUIRED MEDICAL ATTENTION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006194 ↗
• MalfunctionAug 14, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT AN OPERATOR WAS INJURED WHILE TROUBLESHOOTING A TRACK MOTOR JAM ON THE APTIO AUTOMATION SYSTEM. THE OPERATOR NOTICED A SAMPLE TUBE CARRIER JAM. THE TRACK MOTOR AND CARRIER BELT WERE WORKING (ROTATING). THE OPERATOR REMOVED THE LOWER SIDE PANEL WHILE THE UPPER SIDE PANEL REMAINED INSTALLED ON THE TRACK AND REACHED INTO THE MODULE TO TROUBLESHOOT. THE OPERATOR'S FINGER WAS CAUGHT BETWEEN THE COGGED BELT AND MOTOR GEAR, RESULTING IN AN INJURY. THE OPERATOR WAS TAKEN TO A HOSPITAL WHERE AN OPERATION WAS PERFORMED ON THE FINGER, THE OPERATOR WAS IN THE HOSPITAL ONE DAY AND SENT HOME FOR RECOVERY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19982108 ↗
• MalfunctionAug 8, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT AN OPERATOR WAS INJURED WHILE TROUBLESHOOTING A TRACK MOTOR JAM ON THE APTIO AUTOMATION SYSTEM. THE OPERATOR NOTICED A SAMPLE TUBE CARRIER JAM. THE TRACK MOTOR AND CARRIER BELT WERE WORKING (ROTATING). THE OPERATOR REMOVED THE LOWER SIDE PANEL WHILE THE UPPER SIDE PANEL REMAINED INSTALLED ON THE TRACK AND REACHED INTO THE MODULE TO TROUBLESHOOT. THE OPERATOR¿S FINGER WAS CAUGHT BETWEEN THE COGGED BELT AND MOTOR GEAR, RESULTING IN AN INJURY. THE OPERATOR WAS TAKEN TO A HOSPITAL WHERE AN OPERATION WAS PERFORMED ON THE FINGER, THE OPERATOR WAS IN THE HOSPITAL ONE DAY AND SENT HOME FOR RECOVERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19941091 ↗
• MalfunctionJun 7, 2024Intermittent Communication Failure; Intermittent Communication Failure

  THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT AN APTIO BY SIEMENS AUTOMATION SYSTEM PUT TWO SAMPLE ID LABELS ON ONE TUBE. THE SAMPLE IDS WERE FROM TWO DIFFERENT PATIENTS WITH SAMPLE IDS (B)(6). THE TUBE WAS NOT PROCESSED ON THE AUTOMATION SYSTEM. THE CUSTOMER INDICATED A NEW SAMPLE WAS REQUESTED FOR BOTH PATIENTS. REPEAT TESTING WAS PERFORMED ON ALTERNATE SAMPLES. THERE ARE NO REPORTS OF INJURY DUE TO THE EVENT. THERE ARE NO REPORTS THAT A TEST RESULT CAUSED A MEDICAL PROCEDURE TO BE DELAY OR WITHHELD. THERE ARE NO REPORTS OF HARM TO PATIENT OR OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485887 ↗
• MalfunctionMay 17, 2024Intermittent Communication Failure; Intermittent Communication Failure

  THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT AN APTIO BY SIEMENS AUTOMATION SYSTEM PUT TWO SAMPLE ID LABELS ON ONE TUBE. THE SAMPLE IDS WERE FROM TWO DIFFERENT PATIENTS WITH SAMPLE IDS (B)(6) AND (B)(6). THE TUBE WAS NOT PROCESSED ON THE AUTOMATION SYSTEM. THE CUSTOMER INDICATED A NEW SAMPLE WAS REQUESTED FOR BOTH PATIENTS. REPEAT TESTING WAS PERFORMED ON THE ALTERNATE SAMPLES. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346044 ↗
• MalfunctionMay 17, 2023Output Problem; Output Problem

  SIEMENS HEALTHCARE INVESTIGATED AN INTERNAL COMPLAINT FOR THE APTIO AUTOMATION STORAGE AND RETRIEVAL MODULE (SRM) THAT MAY LEAD TO AN INCORRECT ASSOCIATION OF TEST RESULT(S) TO A SAMPLE ID AND THEREFORE TO AN INCORRECT PATIENT RESULT. THE MIS-ASSOCIATION OF TEST RESULTS, OR A DELAY IN TESTING, MAY OCCUR WHEN ALL THE FOLLOWING CONDITIONS OCCUR: THE SRM MODULE IS RELEASING A SAMPLE TUBE (TUBE A) JUST PLACED INTO THE CARRIER, ANOTHER SAMPLE TUBE (TUBE B) IS ERRONEOUSLY NOT DIVERTED INTO THE SRM MODULE BUFFER, AND NUMBER 1 AND 2 OCCUR WITHIN A VERY NARROW TIMING WINDOW OF EACH OTHER. 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 16945025 ↗
• MalfunctionDec 1, 2022Use of Device Problem; Use of Device Problem

  MULTIPLE PATIENT SAMPLE TUBES FELL OUT OF THE SAMPLE TUBE CARRIER AND LANDED ON THE CARRIER BELT OF AN APTIO AUTOMATION SYSTEM. THE SAMPLE TUBES WERE BOTH UNCAPPED AND CAPPED. THE UNCAPPED SAMPLE TUBES SPILLED OUT ONTO THE CARRIER BELT. THE CUSTOMER DID NOT PROVIDE THE NUMBER OF SAMPLE TUBES, SAMPLE IDENTIFICATION NUMBERS OR TEST NAMES. 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 15897494 ↗
• MalfunctionNov 3, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SIEMENS WAS INFORMED THAT A MOTOR WAS OVERHEATING ON AN APTIO AUTOMATION SYSTEM BY SIEMENS. A CUSTOMER SERVICE ENGINEER (CSE) WAS ONSITE TO SERVICE THE SYSTEM AND IDENTIFIED THE ALIQUOTER MODULE TUBE TILTER MOTOR WAS HOT AND DISCONNECTED POWER TO THE MOTOR. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE MOTOR OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12747155 ↗
• MalfunctionNov 3, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SIEMENS WAS INFORMED THAT A MOTOR WAS OVERHEATING ON AN APTIO AUTOMATION SYSTEM BY SIEMENS. A CUSTOMER SERVICE ENGINEER (CSE) WAS ONSITE TO SERVICE THE SYSTEM AND IDENTIFIED THE ALIQUOTER MODULE TUBE TILTER MOTOR WAS HOT AND DISCONNECTED POWER TO THE MOTOR. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE MOTOR OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12747152 ↗
• MalfunctionOct 8, 2021Communication or Transmission Problem; Communication or Transmission Problem

  SIEMENS INVESTIGATED AN INTERNAL COMPLAINT FOR THE APTIO AUTOMATION INTERFACE MODULE TO THE ADVIA CENTAUR XP/XPT ANALYZERS. WHEN A SAMPLE TUBE THAT IS TO BE PROCESSED BY THE ADVIA CENTAUR XP/XPT IS NOT DIVERTED INTO THE INTERFACE MODULE DUE TO A MECHANICAL ISSUE OR DUE TO AN OBSTRUCTION, ONE OF THE FOLLOWING SAMPLE TUBE(S) THAT IS DIVERTED INTO THE INTERFACE MODULE TO BE PROCESSED BY THE ADVIA CENTAUR XP/XPT MAY BE RELEASED FROM THE INTERFACE MODULE, FLAGGED WITH THE ERROR CODE 3160 "SAMPLING NOT SUCCESSFUL" AND WITH TEST RESULTS OBTAINED FROM ANOTHER SAMPLE TUBE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598208 ↗
• MalfunctionAug 26, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER INFORMED SIEMENS THAT THE REAR COVER SAFETY SHIELD ON THE APTIO AUTOMATION SYSTEM INPUT/OUTPUT MODULE HAD BEEN BROKEN AND TAMPERED WITH GLUE. SIEMENS REVIEWED THE INFORMATION PROVIDED AND NOTED THE SAFETY SHIELD HAD SOME HINGES THAT WERE MISSING, RE-GLUED, AND BROKEN. SIEMENS INFORMED THE CUSTOMER THAT A NEW COVER WAS REQUIRED BEFORE OPERATING THE SYSTEM DUE TO THE POTENTIAL EXPOSURE AND HAZARD OF MOVING MECHANICAL PARTS. IT IS UNKNOWN IF THE CUSTOMER HAS OPERATED THE SYSTEM WITHOUT A COVER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE BROKEN SAFETY SHIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374514 ↗
• MalfunctionSep 1, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER CONTACTED SIEMENS TO INFORM THAT A STAT CARDIAC TROPONIN SAMPLE TUBE (SAMPLE ID (B)(6)) WAS MISSING FROM THE APTIO AUTOMATION SYSTEM. THE SAMPLE TUBE WAS MISSING AND THE CUSTOMER PERFORMED A REDRAW OF THE PATIENT SAMPLE TO PERFORM TESTING. THE CUSTOMER INFORMED SIEMENS THAT THE SAMPLE TUBE WAS FOUND 4 HOURS LATER AFTER THE REDRAW WAS PERFORMED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DROPPED AND MISSING SAMPLE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10480057 ↗
• MalfunctionAug 21, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT THE OPERATOR OF AN APTIO AUTOMATION SYSTEM CUT HIS FINGER ON THE SHUTTER MECHANISM OF THE STORAGE AND RETRIEVAL MODULE (SRM). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUT ON THE FINGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10439545 ↗
• MalfunctionFeb 10, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2020 A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) OBSERVED SPARKS WHILE REPLACING AN ELECTRICAL RELAY FOR THE BULK INPUT MODULE (BIM) ON AN APTIO AUTOMATION SYSTEM. THERE WAS NO REPORT OF SMOKE OR FLAME. THERE WAS NO DELAY IN PROCESSING SAMPLES ON THE APTIO AUTOMATION SYSTEM. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE OBSERVED SPARKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9687462 ↗
• MalfunctionNov 25, 2019Use of Device Problem; Use of Device Problem

  AN INSTRUMENT OPERATOR WAS EXPOSED TO A HOT SURFACE WHILE PERFORMING MAINTENANCE ON THE TUBE SEALER MODULE OF AN APTIO AUTOMATION SYSTEM. THE OPERATOR REPORTEDLY HAD THEIR THUMB GET CAUGHT IN THE HOT SEALER HEAD. THE SAFETY SHIELD WAS UP ON THE SEALER MODULE. THE OPERATOR WENT TO THE EMERGENCY DEPARTMENT. THE EMERGENCY DEPARTMENT REPORTED THE SKIN ON THE THUMB WAS NOT BROKEN, DID NOT BLEED AND THERE APPEARED TO BE NO DAMAGE TO THE THUMB. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HEAT EXPOSURE FROM THE SEALER MODULE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9369135 ↗
• MalfunctionJul 5, 2019Leak/Splash; Leak/Splash

  THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT ONE PERSON IN THE LAB WAS EXPOSED TO BIOHAZARDOUS WASTE WHILE INSPECTING A LEAK AROUND THE APTIO AUTOMATION SYSTEM. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EXPOSURE TO BIOHAZARDOUS WASTE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8764547 ↗
• MalfunctionJun 21, 2019Use of Device Problem; Use of Device Problem

  AN APTIO BY SIEMENS SYSTEM ATTACHED TO AN ATELLICA SAMPLE HANDLER PRIME SAMPLE HANDLER CONNECT (SHC) INSTRUMENT WAS BEING OPERATED WITH THE PROTECTIVE COVERS REMOVED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO OPERATING AN APTIO BY SIEMENS SYSTEM ATTACHED TO AN ATELLICA SAMPLE HANDLER PRIME SAMPLE HANDLER CONNECT (SHC) INSTRUMENT WITH THE PROTECTIVE COVERS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724381 ↗
• MalfunctionJul 6, 2018Mechanical Problem; Mechanical Problem

  A LOW CREATININE (CRE) TEST RESULT WAS OBTAINED ON AN ALIQUOT FROM THE PRIMARY SAMPLE TUBE ON AN APTIO BY SIEMENS SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PRIMARY SAMPLE WAS REPEATED AND THE REPEAT TEST RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW CREATININE TEST RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667635 ↗
• MalfunctionDec 19, 2017Device Issue; Device Issue

  AN APTIO AUTOMATION SYSTEM WAS DISCOVERED TO BE MISSING THE SAFETY COVER FOR THE ELECTRICAL PLATE INSIDE THE REFRIGERATED STORAGE MODULE (RSM). THERE WERE NO INJURIES DUE TO THE MISSING SAFETY COVER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7128352 ↗
• MalfunctionJul 10, 2017Mechanical Problem; Mechanical Problem

  THE OPERATOR OF AN APTIO AUTOMATION SYSTEM DISCOVERED APPROXIMATELY 10-15 SAMPLE TUBES WHICH HAD DROPPED ONTO THE FLOOR. THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC), BUT DID NOT PROVIDE ANY ADDITIONAL INFORMATION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO POTENTIAL DELAYED TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6698422 ↗
• MalfunctionJul 7, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE REFRIGERATED STORAGE MODULE (RSM) FOR AN APTIO AUTOMATION SYSTEM STOPPED WORKING. THE CUSTOMER STATED THAT SAMPLES LOCATED IN THE RSM COULD NOT BE USED FOR TESTING, AS THE RSM NOT MAINTAINING THE PROPER TEMPERATURE HAD AFFECTED THE SAMPLE INTEGRITY. THE CUSTOMER STATED THAT TWO SAMPLES NEEDED TO BE RECOLLECTED FOR ADDITIONAL TESTING, BUT THE CUSTOMER COULD NOT PROVIDE THE TEST ORDERS FOR THE PATIENTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO DELAYED TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6694269 ↗