Alinity m 08N53-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 950 adverse event reports that list this exact device (DI 00884999048034), received between May 5, 2020 and Sep 28, 2026 — classified as 7 injuries, 943 malfunctions.

The most frequently reported specific device problem is “Program or Algorithm Execution Problem” (302 reports).

4 FDA recall records name this device's identifier, 3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 20, 2025Open, Classified

   The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

   Z-1665-2025 · Root cause: Device Design · FDA record ↗

2. Mar 20, 2024Open, Classified

   The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.

   Z-1602-2024 · Root cause: Under Investigation by firm · FDA record ↗

3. Nov 11, 2022Open, Classified

   The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.

   Z-1349-2023 · Root cause: Under Investigation by firm · FDA record ↗

4. Dec 6, 2021Terminated

   There is an issue with the installation of updated camera firmware on the system.

   Z-0463-2022 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 950 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923204 ↗
• MalfunctionSep 16, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793748 ↗
• MalfunctionSep 16, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792690 ↗
• InjurySep 9, 2026Human-Device Interface Problem

  Patient problems: Skin Tears

  MAUDE report 50698589 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  A Field Service Engineer (FSE) reported a face splash event.The FSE reported while they were working on the System Solution Drawer on the Alinity m System, the tube on waste line 1 disconnected and some sprayed on their face. The immediate action was to wash the impacted area with water. FSE was wearing personal protective equipment (PPE). After that, the FSE went to the Emergency department and in conversation with the infectious disease specialist decided to prescribe them an antiviral. FSE will receive control in 30 days.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380402 ↗
• MalfunctionAug 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308460 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50238498 ↗
• MalfunctionAug 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194961 ↗
• MalfunctionAug 5, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147115 ↗
• MalfunctionAug 4, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132224 ↗
• MalfunctionJul 27, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037222 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK COMING FROM THE INTEGRATED REACTION UNIT (IRU) WASTE DRAWER 1 WHILE USING THE ALINITY M SYSTEM. THE CUSTOMER REPORTED LIQUID WAS OBSERVED UNDER IRU WASTE DRAWER 1. THERE WAS NO LIQUID IN THE IRU WASTE DRAWER 1. THE CUSTOMER REPORTED THERE WAS CRYSTALLIZED LIQUID OUTSIDE OF THE FOOTPRINT OF THE INSTRUMENT PRIOR TO THE FIELD SERVICE ENGINEER (FSE) VISIT. THERE WAS NO DIRECT CONTACT WITH THE OBSERVED FLUID AND ALL APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS WORN. FSE DISCOVERED PERISTALTIC PUMP 5 HAD DISCONNECTED TUBING WHICH CAUSED THE LEAK. FSE RECONNECTED THE TUBING AND CLEANED UP THE LEAK WHILE WEARING ALL APPROPRIATE PPE. THERE WAS NO PATIENT INVOLVED AS THE LEAK WAS IDENTIFIED BY THE ALINITY M SYSTEM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221031 ↗
• MalfunctionApr 27, 2026Unable to Obtain Readings

  CUSTOMER REPORTED THAT THEIR ALINITY M STI CONTROLS FAILED FOR POSITIVE CONTROL NON REACTIVE. ABBOTT HAS IDENTIFIED AN INCREASE OF INCIDENCES REGARDING POSITIVE CONTROL NONREACTIVES WHILE USING THE ALINITY M HR HPV AMP KIT AND ALINITY M STI AMP KIT. INVALIDATED POSITIVE ASSAY CONTROLS CAN BE TRACED TO IRON LEACHING INTO THE ALINITY M LYSIS SOLUTION FROM THE LYSIS TRANSFER PUMP IN THE ALINITY M SYSTEM. THERE IS A POTENTIAL FOR NON-REACTIVE POSITIVE CONTROLS TO OCCUR WHILE USING ALINITY M HR HPV AND ALINITY M STI AMP KITS. METAL LEACHING IN THE LYSIS BUFFER CAN LEAD TO INVALIDATED HPV AND STI POSITIVE ASSAY CONTROLS. THE INVALIDATED PATIENT SAMPLES WILL NEED TO BE REPROCESSED, RESULTING IN A POSSIBLE DELAY IN RESULT REPORTING. IT HAS BEEN DETERMINED THAT THERE IS NO IMPACT TO RESULTS GENERATED IF VALID CONTROLS ARE OBTAINED. NO OTHER ALINITY M ASSAYS ARE IMPACTED. A DECISION WAS MADE TO ISSUE A CUSTOMER LETTER TO NOTIFY CUSTOMERS OF THE REPORTED ISSUE. THIS FIELD ACTION, FA-AM-SEP2024-300 WAS ISSUED ON SEPTEMBER 12, 2024. FIELD ACTION WAS REPORTED PER 21CFR806 TO US FDA VIA 3005248192-09/12/24-003-C ON SEPTEMBER 17, 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001309 ↗
• MalfunctionApr 11, 2026Unable to Obtain Readings

  CUSTOMER REPORTED THAT THEIR ALINITY M STI CONTROLS FAILED FOR POSITIVE CONTROL NON REACTIVE. ABBOTT HAS IDENTIFIED AN INCREASE OF INCIDENCES REGARDING POSITIVE CONTROL NONREACTIVES WHILE USING THE ALINITY M HR HPV AMP KIT AND ALINITY M STI AMP KIT. INVALIDATED POSITIVE ASSAY CONTROLS CAN BE TRACED TO IRON LEACHING INTO THE ALINITY M LYSIS SOLUTION FROM THE LYSIS TRANSFER PUMP IN THE ALINITY M SYSTEM. THERE IS A POTENTIAL FOR NON-REACTIVE POSITIVE CONTROLS TO OCCUR WHILE USING ALINITY M HR HPV AND ALINITY M STI AMP KITS. METAL LEACHING IN THE LYSIS BUFFER CAN LEAD TO INVALIDATED HPV AND STI POSITIVE ASSAY CONTROLS. THE INVALIDATED PATIENT SAMPLES WILL NEED TO BE REPROCESSED, RESULTING IN A POSSIBLE DELAY IN RESULT REPORTING. IT HAS BEEN DETERMINED THAT THERE IS NO IMPACT TO RESULTS GENERATED IF VALID CONTROLS ARE OBTAINED. NO OTHER ALINITY M ASSAYS ARE IMPACTED. A DECISION WAS MADE TO ISSUE A CUSTOMER LETTER TO NOTIFY CUSTOMERS OF THE REPORTED ISSUE. THIS FIELD ACTION, FA-AM-SEP2024-300 WAS ISSUED ON SEPTEMBER 12, 2024. FIELD ACTION WAS REPORTED PER 21CFR806 TO US FDA VIA 3005248192-09/12/24-003-C ON SEPTEMBER 17, 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847867 ↗
• MalfunctionApr 7, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK WHILE USING THE ALINITY M INSTRUMENT. THE CUSTOMER REPORTED A LIQUID THAT WAS BROWN IN COLOR UNDERNEATH THE ALINITY M INSTRUMENT. THE LIQUID WAS OUTSIDE OF THE FOOTPRINT OF THE INSTRUMENT. THERE WAS NO INJURY OR EXPOSURE TO THE LIQUID. THERE WAS NO PATIENT INVOLVED AS THE LEAK WAS IDENTIFIED BY THE ALINITY M SYSTEM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811065 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED A DILUENT LEAK FROM THEIR ALINITY M SYSTEM. THE CUSTOMER REPORTED THAT DILUENT WAS NOT TRANSFERRING AND RECEIVED A TRANSFER ERROR. UPON OPENING THE DRAWER, THEY FOUND A DILUENT LEAK. THE LIQUID HAD REACHED OUTSIDE THE INSTRUMENT FOOTPRINT AND WAS DRIPPING FROM THE DRAWER ONTO THE FLOOR. A FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING AND LOG FILE ANALYSIS. THE RESERVOIR SINGLE TUBE SENSOR WAS REPLACED AND PASSED ALL TESTS. THE INSTRUMENT IS WORKING PER SPECIFICATION AND THE CUSTOMER ACCEPTED THE INSTRUMENT FOR ROUTINE USE. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727951 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK WHILE USING THE ALINITY M INSTRUMENT SERIAL NUMBER (SN) (B)(6). THE CUSTOMER REPORTED LIQUID LEAKING OUTSIDE OF THE SYSTEM SOLUTIONS DRAWER. THE CUSTOMER NOTED DARK BROWN LIQUID DRIPPING SLOWLY FROM THE FRONT RIGHT CORNER OF THE INSTRUMENT, FORMING A STALACTITE. THE LEAKAGE REACHED THE FLOOR OUTSIDE OF THE FOOTPRINT OF THE INSTRUMENT BUT DID NOT FORM A PUDDLE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AND THERE WAS NO SKIN CONTACT WITH THE LIQUID. THERE WAS NO INJURY RELATED TO THE REPORTED LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681749 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK ON THEIR ALINITY M SYSTEM. THE CUSTOMER REPORTED THAT THEY FOUND THE TOP OF THE LIQUID WASTE BOTTLE 2 WAS NOT SEALED PROPERLY. LIQUID HAD COME OUT FROM THE LIQUID WASTE TUBE AND SPREAD IN THE SYSTEM SOLUTIONS DRAWER. THE CUSTOMER ALSO FOUND LIQUID IN THE TRAY AND ON THE FLOOR. THE SPILL HAD SPREAD OUTSIDE OF THE INSTRUMENT AND ONTO THE WALKING PATH. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE CLEANED THE INSTRUMENT AND REPLACED THE WASTE BOTTLE TUBING AND PERFORMED CHECKS. THE INSTRUMENT WAS WORKING AS EXPECTED. THERE WAS NO REPORT OF INJURY OR ANY ACTUAL EXPOSURE TO THE LEAKED LIQUID. THERE WAS NO PATIENT INVOLVED AS THE LEAK WAS IDENTIFIED BY THE ALINITY M SYSTEM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640050 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK ON THEIR ALINITY M SYSTEM. THE CUSTOMER REPORTED OBSERVING A LEAK FORMING IN FRONT OF THE INSTRUMENT. THE CUSTOMER REPORTED LIQUID IN THE AREA OF THE AMPLIFIED WASTE BIN OF THE SYSTEMS SOLUTIONS DRAWER. THERE WAS ALSO SOME CRYSTALLIZATION OBSERVED IN THE SYSTEM SOLUTIONS DRAWER. THE LEAK WENT ONTO THE WALKING SURFACE. IT WAS CONTAINED AND CLEARLY MARKED SO NO ONE COULD SLIP. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND THAT ONE OF THE TUBES COMING FROM THE BULKFILL ASSEMBLY HAD A KINK AND CAUSED A BACKFLOW, HENCE THE LEAK. THE FSE STRAIGHTENED THE TUBING AND CLEANED UP THE BULKFILL AND THE SYSTEM SOLUTIONS DRAWER. THERE WAS NO REPORT OF INJURY OR ANY ACTUAL EXPOSURE TO THE LEAKED LIQUID. THERE WAS NO PATIENT INVOLVED AS THE LEAK WAS IDENTIFIED BY THE ALINITY M SYSTEM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608172 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK ON THEIR ALINITY M SYSTEM. THE CUSTOMER REPORTED AN INSTRUMENT LEAK OF VAPOR BARRIER ON THEIR ALINITY M INSTRUMENT. LIQUID HAD LEFT THE FOOTPRINT OF THE INSTRUMENT. THE CUSTOMER TURNED OFF THE INSTRUMENT AND CLEANED THE WALKING AREA WHILE WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND A LEAKING VAPOR BARRIER RESERVOIR AND REPLACED IT. THERE WAS NO REPORT OF INJURY OR ANY ACTUAL EXPOSURE TO THE LEAKED LIQUID. THERE WAS NO PATIENT INVOLVED AS THE LEAK WAS IDENTIFIED BY THE ALINITY M SYSTEM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558285 ↗
• MalfunctionMar 2, 2026Unable to Obtain Readings

  CUSTOMER REPORTED THAT THEIR ALINITY M STI CONTROLS FAILED FOR POSITIVE CONTROL NON REACTIVE. ABBOTT HAS IDENTIFIED AN INCREASE OF INCIDENCES REGARDING POSITIVE CONTROL NON REACTIVES WHILE USING THE ALINITY M HR HPV AMP KIT AND ALINITY M STI AMP KIT. INVALIDATED POSITIVE ASSAY CONTROLS CAN BE TRACED TO IRON LEACHING INTO THE ALINITY M LYSIS SOLUTION FROM THE LYSIS TRANSFER PUMP IN THE ALINITY M SYSTEM. THERE IS A POTENTIAL FOR NON-REACTIVE POSITIVE CONTROLS TO OCCUR WHILE USING ALINITY M HR HPV AND ALINITY M STI AMP KITS. METAL LEACHING IN THE LYSIS BUFFER CAN LEAD TO INVALIDATED HPV AND STI POSITIVE ASSAY CONTROLS. THE INVALIDATED PATIENT SAMPLES WILL NEED TO BE REPROCESSED, RESULTING IN A POSSIBLE DELAY IN RESULT REPORTING. IT HAS BEEN DETERMINED THAT THERE IS NO IMPACT TO RESULTS GENERATED IF VALID CONTROLS ARE OBTAINED. NO OTHER ALINITY M ASSAYS ARE IMPACTED. A DECISION WAS MADE TO ISSUE A CUSTOMER LETTER TO NOTIFY CUSTOMERS OF THE REPORTED ISSUE. THIS FIELD ACTION, FA-AM-SEP2024-300 WAS ISSUED ON SEPTEMBER 12, 2024. FIELD ACTION WAS REPORTED PER 21CFR806 TO US FDA VIA 3005248192-09/12/24-003-C ON SEPTEMBER 17, 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491312 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK ON THEIR ALINITY M SYSTEM. THE CUSTOMER REPORTED THAT SOLUTION WAS LEAKING FROM INSIDE THE SOLUTIONS DRAWER AND POOLING ON THE FLOOR IN FRONT OF THE INSTRUMENT. APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS WORN WHEN THE SPILL WAS CLEANED. THERE WAS NO EXPOSURE TO THE LIQUID AND NO INJURY. THERE WAS NO PATIENT INVOLVED AS THE LEAK WAS IDENTIFIED BY THE ALINITY M SYSTEM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429626 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  CUSTOMER CALLED TO REPORT A DILUENT LEAK ON THEIR ALINITY M SYSTEM. CUSTOMER LOADED A NEW DILUENT BOTTLE IN THE MORNING AND IT STARTED LEAKING OUT OF THE BOTTOM OF THE ANALYZER UNDER THE SOLUTIONS DRAWER (OUTSIDE OF THE FOOTPRINT). CUSTOMER THEN PERFORMED A SHUTDOWN AND STARTUP AND HAS SINCE BEEN GETTING SYSTEM SOLUTION (DILUENT) TRANSFER ERRORS. LEAKAGE OCCURRED RIGHT WHEN THE TRANSFER SHOULD HAVE HAPPENED; THE DILUENT SEEMED TO BE GOING STRAIGHT FROM THE BOTTLE TO THE FLOOR. CUSTOMER CLEANED THE FLOOR WEARING PROTECTIVE GEAR AT ALL TIMES. NO ACCIDENT OR INJURY OCCURRED. CUSTOMER WAS NOT ABLE TO PROVIDE PICTURES AS THEY HAD CLEANED THE LEAKAGE PRIOR TO CALLING THE TICKET IN. THE CUSTOMER STATED THAT THE VOLUME OF LEAKED LIQUID WAS LARGE; LEAK WAS SUBSTANTIAL ON THE BOTTOM INSIDE THE INSTRUMENT, BUT ALSO LEAKED OUTSIDE THE FOOTPRINT OF THE INSTRUMENT ONTO THE WALKWAY WHERE THEY HAD TO USE TISSUES TO SOAK IT UP. FIELD SERVICE ENGINEER VISIT CONFIRMED THAT THE FLOAT SENSOR FAILED. FLOAT SENSOR WAS REPLACED PER THE SERVICE MANUAL AND WAS CONFIRMED TO BE READING CORRECTLY. THERE WAS NO PATIENT INVOLVED AS THE LEAK WAS IDENTIFIED BY THE ALINITY M SYSTEM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284397 ↗
• MalfunctionFeb 5, 2026Unable to Obtain Readings

  CUSTOMER REPORTED THAT THEIR ALINITY M STI CONTROLS FAILED FOR POSITIVE CONTROL NON REACTIVE. ABBOTT HAS IDENTIFIED AN INCREASE OF INCIDENCES REGARDING POSITIVE CONTROL NONREACTIVES WHILE USING THE ALINITY M HR HPV AMP KIT AND ALINITY M STI AMP KIT. INVALIDATED POSITIVE ASSAY CONTROLS CAN BE TRACED TO IRON LEACHING INTO THE ALINITY M LYSIS SOLUTION FROM THE LYSIS TRANSFER PUMP IN THE ALINITY M SYSTEM. THERE IS A POTENTIAL FOR NON-REACTIVE POSITIVE CONTROLS TO OCCUR WHILE USING ALINITY M HR HPV AND ALINITY M STI AMP KITS. METAL LEACHING IN THE LYSIS BUFFER CAN LEAD TO INVALIDATED HPV AND STI POSITIVE ASSAY CONTROLS. THE INVALIDATED PATIENT SAMPLES WILL NEED TO BE REPROCESSED, RESULTING IN A POSSIBLE DELAY IN RESULT REPORTING. IT HAS BEEN DETERMINED THAT THERE IS NO IMPACT TO RESULTS GENERATED IF VALID CONTROLS ARE OBTAINED. NO OTHER ALINITY M ASSAYS ARE IMPACTED. A DECISION WAS MADE TO ISSUE A CUSTOMER LETTER TO NOTIFY CUSTOMERS OF THE REPORTED ISSUE. THIS FIELD ACTION, FA-AM-SEP2024-300 WAS ISSUED ON SEPTEMBER 12, 2024. FIELD ACTION WAS REPORTED PER 21CFR806 TO US FDA VIA 3005248192-09/12/24-003-C ON SEPTEMBER 17, 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273639 ↗
• MalfunctionFeb 5, 2026Unable to Obtain Readings

  CUSTOMER REPORTED THAT THEIR ALINITY M STI CONTROLS FAILED FOR POSITIVE CONTROL NON REACTIVE. ABBOTT HAS IDENTIFIED AN INCREASE OF INCIDENCES REGARDING POSITIVE CONTROL NONREACTIVES WHILE USING THE ALINITY M HR HPV AMP KIT AND ALINITY M STI AMP KIT. INVALIDATED POSITIVE ASSAY CONTROLS CAN BE TRACED TO IRON LEACHING INTO THE ALINITY M LYSIS SOLUTION FROM THE LYSIS TRANSFER PUMP IN THE ALINITY M SYSTEM. THERE IS A POTENTIAL FOR NON-REACTIVE POSITIVE CONTROLS TO OCCUR WHILE USING ALINITY M HR HPV AND ALINITY M STI AMP KITS. METAL LEACHING IN THE LYSIS BUFFER CAN LEAD TO INVALIDATED HPV AND STI POSITIVE ASSAY CONTROLS. THE INVALIDATED PATIENT SAMPLES WILL NEED TO BE REPROCESSED, RESULTING IN A POSSIBLE DELAY IN RESULT REPORTING. IT HAS BEEN DETERMINED THAT THERE IS NO IMPACT TO RESULTS GENERATED IF VALID CONTROLS ARE OBTAINED. NO OTHER ALINITY M ASSAYS ARE IMPACTED. A DECISION WAS MADE TO ISSUE A CUSTOMER LETTER TO NOTIFY CUSTOMERS OF THE REPORTED ISSUE. THIS FIELD ACTION, FA-AM-SEP2024-300 WAS ISSUED ON SEPTEMBER 12, 2024. FIELD ACTION WAS REPORTED PER 21CFR806 TO US FDA VIA 3005248192-09/12/24-003-C ON SEPTEMBER 17, 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273629 ↗