Aptio Automation AP2Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07640172342008), received between Dec 18, 2018 and Aug 6, 2025 — classified as 6 deaths, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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-1563-2023 · 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-1560-2023 · 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-1562-2023 · 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-1561-2023 · 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 ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THEY OBSERVED AN ISSUE WITH THE CENTRIFUGE MODULE (CM3, NODE 7) OF THEIR APTIO AUTOMATION SYSTEM. THE CENTRIFUGE MODULE IS THE INTERFACE WHICH CONNECTS THE TRACK TO THE CENTRIFUGE (THIRD-PARTY PRODUCT). ACCORDING TO THE CUSTOMER MULTIPLE SAMPLES WENT TO CM3, LEFT THE MODULE WITHOUT BEING SPUN AND WERE SENT TO A THIRD-PARTY INSTRUMENT (ATELLICA) FOR THE ANALYSIS. SOME OF THE INCORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). NO SPECIFIC INFORMATION ABOUT THE PERFORMED TESTS AND THE OBTAINED RESULTS HAVE BEEN PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727328 ↗
• MalfunctionOct 28, 2022Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT, WHEN THEY ORDERED THE RETRIEVE OF A SAMPLE TUBE FROM THE STORAGE AND RETRIEVAL MODULE (SRM) OF THE APTIO AUTOMATION, THE SAMPLE TUBE WAS LOST. THE STORAGE AND RETRIEVAL MODULE STORES SAMPLE TUBES FROM THE AUTOMATION SYSTEM IN A TEMPERATURE CONTROLLED AND PROTECTED ENVIRONMENT. THE EVENT CAUSED A DELAY IN THE EXECUTION OF ADDITIONAL TESTS ORDERED ON THE SAMPLE TUBE. THE CUSTOMER DID NOT REPORT ANY CONSEQUENCE ON THE STATE OF HEALTH AND MEDICAL TREATMENT OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690358 ↗
• MalfunctionOct 6, 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 EVENT OCCURRED AT THE BIOPLEX 2200 INTERFACE MODULE (IM) WHICH CONNECTS THE THIRD PARTY'S ANALYZER TO THE INPECO APTIO AUTOMATION TRACK. THE THIRD PARTY'S ANALYZER IS A "POINT OF SPACE", THUS IS ABLE TO SAMPLE THE TUBE WITHOUT REMOVING IT FROM THE AUTOMATION TRACK. THE CUSTOMER REPORTED THAT A SAMPLE TUBE AT THE SAMPLING POSITION OF THE BIOPLEX 2200 INTERFACE MODULE WAS ASPIRATED 4 TIMES AND THAT THE TEST RESULTS OBTAINED FROM THIS TUBE WERE ASSOCIATED ALSO TO THE OTHER 3 SAMPLE TUBES IN QUEUE INSIDE THE IM PIT LANE. THE CUSTOMER DID NOT REPORT ANY IMPACT ON THE INVOLVED PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549736 ↗
• MalfunctionMay 13, 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 SEVERAL CASES OF MISREAD SAMPLE TUBE IDS (SIDS) ON THE TUBE IDENTIFICATION MODULES AT THE INPUT MODULES. IN CASE THE MISREAD SID BELONGS TO A SAMPLE TUBE (TUBE B) WHICH IS EXPECTED TO BE LOADED ON THE AUTOMATION SYSTEM AND HAS PENDING TEST ORDERS, THE WRONGLY IDENTIFIED SAMPLE TUBE (TUBE A) IS TESTED ACCORDING TO THE ORDERS RECEIVED FOR TUBE B. IF THE SAMPLE TUBES IS SENT TO A MODULE OR TO A THIRD PARTY ANALYZER WHICH CHECKS THE SAMPLE ID THE SAMPLE TUBE IS FLAGGED WITH SAMPLE ID MISMATCH ERROR AND IT IS SENT TO THE INPUT/OUTPUT MODULE. OTHERWISE, IF THE TESTS ARE EXECUTED BY AN ANALYZER WHICH DO NOT READ THE SID, THE MISMATCH ERROR IS NOT DETECTED AND THE TEST RESULTS ARE ASSOCIATED TO THE WRONG PATIENT. WHEN THE SAMPLE TUBE B IS ACTUALLY LOADED ON THE AUTOMATION SYSTEM IT IS FLAGGED WITH ERROR SC00E "DUPLICATE SAMPLE ID" AND UNLOADED INTO THE PRIORITY OUTPUT RACK OF THE INPUT OUTPUT MODULE TO BE MANUALLY HANDLED BY THE OPERATORS. NO CASES OF ACTUAL ERRONEOUS RESULTS NOR IMPACTS ON PATIENT CARE HAVE BEEN REPORTED FROM THE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14394612 ↗
• DeathJul 21, 2021Installation-Related Problem; Installation-Related Problem

  THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT FLAGGED D-DIMER TEST RESULTS (AN M FLAG SIGNIFYING A RESULT >20) WERE OBTAINED FROM A NON-SIEMENS INSTRUMENT AND WERE TRANSMITTED TO A NON-SIEMENS APTIO AUTOMATION DATA MANAGEMENT SYSTEM (DMS). THE DMS SENT A RESULT OF 0 (ZERO), AND NO M FLAG, TO UPSTREAM MIDDLEWARE AND A LABORATORY INFORMATION SYSTEM (LIS). THE CUSTOMER INDICATED THAT THIS SCENARIO OCCURRED ON THREE PATIENTS WHO LATER EXPIRED. THE LABORATORY'S HEMATOLOGIST STATED THE D-DIMER TEST RESULTS DID NOT CAUSE THE PATIENTS' EXPIRATION. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVEN'T BEEN VERIFIED. THE LEGAL MANUFACTURER, INPECO SA, FILED MDR 30108257766-2021-00008 WITH THE FDA ON 12-JUL-2021.

  Patient problems: Insufficient Information

  MAUDE report 12204318 ↗
• DeathJul 12, 2021Installation-Related Problem; Installation-Related Problem

  THE AUTOMATION SYSTEM DATA MANAGEMENT SOFTWARE (DMS) HAS SENT TO THE UPPER MIDDLEWARE INCORRECT D-DIMER TEST RESULTS ASSOCIATED TO 13 SAMPLE TUBES. THE ANALYZER STA R MAX, MANUFACTURED BY STAGO, SENT TO DMS THE D-DIMER TEST RESULTS > 20 WITH THE FLAG M (MAX), DMS DID NOT TRANSMIT THE FLAG AND REPORTED TO THE UPPER MIDDLEWARE THE OUT OF RANGE RESULTS AS 0. ACCORDING TO THE INFORMATION RECEIVED FROM THE FIELD 3 OF THESE PATIENTS PASSED AWAY. HOWEVER THE LABORATORY HAEMATOLOGIST SPECIFIED THAT THE D-DIMER RESULTS DID NOT CAUSE THE PATIENTS' DEATH.

  Patient problems: Insufficient Information

  MAUDE report 12150638 ↗
• MalfunctionApr 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A TUBE WITH SAMPLE IDENTIFICATION NUMBER (SID) (B)(6) WAS RELEASED BY THE STAGO STA-R ANALYZER INTERFACE MODULE WITH THE ERROR SC00E "DUPLICATE SAMPLE ID". ACCORDING TO THE GRAPHICAL USER INTERFACE, THAT SID WAS LOCATED IN A SORTING RACK OF THE INPUT OUTPUT MODULE (IOM), BUT WHEN THE OPERATOR TOOK THE SAMPLE TUBE FROM THE SORTING RACK, HE SAW THAT THE SID WAS NOT (B)(6). THE REAL SID (B)(6) WAS IN ANOTHER RACK OF THE IOM NAMED (B)(6). THE STAGO STA-R ANALYZER IS NOT UNDER INPECO RESPONSIBILITY AND IT IS CONNECTED TO THE INPECO APTIO AUTOMATION SYSTEM THROUGH AN INTERFACE MODULE, COMPOSED BY A "PICK AND PLACE" ROBOTIC SAMPLE MOVING DEVICE DESIGNED TO TRANSFER THE SAMPLE TUBES TO AND FROM THE ANALYZER. THE INTERFACE MODULE HAS A BARCODE READER AT THE EXIT OF THE MODULE, WHICH READS THE SID ON THE LABEL OF THE SAMPLE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642219 ↗
• MalfunctionNov 18, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Imprecise or Erratic Results; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Imprecise or Erratic Results

  THE CUSTOMER REPORTED TWO OCCURRENCES ABOUT POTENTIAL DISCREPANT RESULTS OBTAINED FOR SAMPLE TUBES PROCESSED AT THE ADVIA CENTAUR ANALYZER CONNECTED TO THE INPECO APTIO AUTOMATION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10862129 ↗
• DeathDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRODUCT DISTRIBUTOR NOTIFIED INPECO THAT ON (B)(6) 2019 A PATIENT ARRIVED AT THE EMERGENCY ROOM (ER) OF THE HOSPITAL AND EXPIRED. THE PATIENT HAD A TUBE CLASSIFIED AS PRIORITY (STAT) WITH A TEST ORDER FOR TROPONIN (TNIH), THE CUSTOMER REPORTED A DELAY FOR THE TROPONIN RESULT OF MORE THAN 1 HOUR. THE EMERGENCY ROOM NURSE FOLLOWED UP ON THE TROPONIN RESULTS MULTIPLE TIMES, MAKING THE LABORATORY OPERATOR AWARE OF THE DELAY. THE CUSTOMER DID NOT PROVIDE THE CAUSE OF THE PATIENT EXPIRING, NOR THE MEDICATIONS THAT WERE BEING TAKEN AT THE TIME OF THE EVENT. NO INFORMATION WAS PROVIDED ABOUT THE POSSIBILITY THAT A MEDICAL PROCEDURE WAS PERFORMED, DELAYED OR WITHHELD DUE TO THE DELAY.

  Patient problems: Death

  MAUDE report 9529546 ↗
• DeathDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL MDR 3007494875-2019-00002 WAS FILED ON 20-DEC-2019. ADDITIONAL INFORMATION (30-DEC-2019): THE MANUFACTURER OF THE DEVICE SUBMITTED MDR 3010825766-2019-00014 ON 30-DEC-2019.

  Patient problems: Death

  MAUDE report 9505082 ↗
• MalfunctionDec 20, 2019Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  THE CUSTOMER NOTIFIED A MALFUNCTION OF THE ALIQUOTER MODULE: THE CUSTOMER SUPPOSED THAT, IN CASE OF "CLOT DETECTION ERROR", A LITTLE AMOUNT OF WATER FROM THE ALIQUOTER HYDRAULIC CIRCUIT MAY BE DISPENSED INTO THE PRIMARY TUBE LEADING TO SAMPLE DILUTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9503932 ↗
• DeathAug 16, 2019Use of Device Problem; Use of Device Problem

  SIEMENS FILED THE INITIAL MDR 3007494875-2019-00001 ON 16-AUGUST-2019. ADDITIONAL INFORMATION (22-AUGUST-2019): THE CUSTOMER INFORMS THAT NOVOSEVEN TREATMENT WAS DELAYED. SIEMENS PERFORMED A FOLLOW-UP WITH THE CUSTOMER, AND THE CUSTOMER PROVIDES NO ADDITIONAL INFORMATION.

  Patient problems: Death

  MAUDE report 8901772 ↗
• DeathJul 31, 2019Use of Device Problem; Use of Device Problem

  THE PRODUCT DISTRIBUTOR HAS NOTIFIED INPECO THAT A SAMPLE TUBE OF A PATIENT ARRIVED AT THE HOSPITAL FOR AN HEMORRHAGIC SHOCK WAS LOADED ON THE AUTOMATION SYSTEM ON (B)(6) 2019. THE CUSTOMER REPORTED THAT THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 8845999 ↗
• MalfunctionMay 15, 2019Smoking; Smoking

  THE PRODUCT DISTRIBUTOR HAS NOTIFIED INPECO THAT, DURING THE INSTALLATION PHASE OF THE AUTOMATION SYSTEM, SMOKE AND BURNING SMELL WERE COMING FROM THE SIRIUS BOARD (ELECTRONIC BOARD) OF THE ACTIVE TRACK RETURN (ATR). ATR IS A DEVICE THAT ALLOWS THE CARRIER TO RETURN TO THE MAIN LANE OF THE TRACK FROM THE SECONDARY LANE, AVOIDING COLLISION WITH CARRIERS COMING FORM THE MAIN LANE. THE BOARD WAS FOUND BURNED AND IT WAS REPLACED BY THE PRODUCT DISTRIBUTOR SERVICE PERSONNEL (FSE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612226 ↗
• MalfunctionFeb 1, 2019Smoking; Smoking

  THE PRODUCT DISTRIBUTOR HAS NOTIFIED INPECO THAT SMOKE AND STRONG SMELL WERE COMING FROM THE COOLING UNIT OF THE STORAGE AND RETRIEVAL MODULE (SRM). THE SRM STORES SAMPLE TUBES FROM THE AUTOMATION SYSTEM IN A TEMPERATURE CONTROLLED AND PROTECTED ENVIRONMENT. NEITHER THE LABORATORY STAFF NOR THE SERVICE PERSONNEL (FSE) WERE INJURED DUE TO THE EVENT. THERE WAS NO NEED FOR THE LABORATORY TO BE EVACUATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8296682 ↗
• MalfunctionDec 18, 2018Mechanical Problem; Manufacturing, Packaging or Shipping Problem; Mechanical Problem; Manufacturing, Packaging or Shipping Problem

  THE PRODUCT DISTRIBUTOR HAS NOTIFIED INPECO THAT STOP GATES BECOME "STUCK" AND TRACK JAMS AND SPLASHING OCCURS. THE SAMPLE SPLASH FROM TUBES MAY CAUSE CROSS CONTAMINATION. THE COVERS AVOID THAT THE OPERATORS CAN COME IN CONTACT WITH THE SPILLED SAMPLE. NOTE: THE STOP GATE IS THE GATE ON THE AUTOMATION MAIN TRACK WHICH IS ACTIVATED TO TEMPORARY STOP THE SAMPLE CARRIERS ROUTING TO ALLOW THE SAMPLE CARRIER RETURN FROM THE MODULE/INTERFACE MODULE BUFFER TO THE MAIN TRACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8173266 ↗

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-0595-2026 · Oct 30, 2025 · Open, Classified
  FlexLab (FLX); Version: FLX-217-10;
• Z-0596-2026 · Oct 30, 2025 · Open, Classified
  FlexLab (FLX); Version: FLX-217-40;
• Z-0106-2026 · Sep 3, 2025 · Open, Classified
  FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
• Z-0107-2026 · Sep 3, 2025 · Open, Classified
  FlexLab X (FXX) 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-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-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-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-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-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-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-2199-2020 · Apr 7, 2020 · Open, Classified
  Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstat
• 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.

…and 13 more.