Alinity mRecalls & reported problems across all models

We found 13 models of Alinity m by Abbott Molecular Inc. in the FDA's device registry (GUDID). Together they are named in 1,534 adverse event reports in the FDA's MAUDE database, received between May 5, 2020 and Sep 28, 2026 — classified as 7 injuries, 1,527 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (559 reports).

14 FDA recall records name at least one of these models by its device identifier, 7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Alinity m recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. Sep 12, 2024Open, Classified

   Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain 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.

   Z-0234-2025 · Root cause: Device Design · Recall details · FDA record ↗

3. Sep 12, 2024Open, Classified

   Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain 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.

   Z-0233-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. 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 · Recall details · FDA record ↗

5. Oct 30, 2023Open, Classified

   Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.

   Z-0407-2024 · Root cause: Other · Recall details · FDA record ↗

6. 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 · Recall details · FDA record ↗

7. Aug 19, 2022Open, Classified

   Reports received of an increase of message code 9186 (internal control failed) when using the kit.

   Z-1679-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Feb 11, 2022Terminated

   There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.

   Z-0710-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. Dec 6, 2021Terminated

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

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

10. Sep 2, 2021Terminated

    There is a potential for false positive results.

    Z-0008-2022 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

11. Sep 2, 2021Terminated

    There is a potential for false positive results.

    Z-0007-2022 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

12. Sep 2, 2021Terminated

    There is a potential for false positive results.

    Z-0006-2022 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

13. Sep 2, 2021Terminated

    There is a potential for false positive results.

    Z-0005-2022 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

14. Sep 2, 2021Terminated

    There is a potential for false positive results.

    Z-0004-2022 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported Alinity m problems

Alinity m models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Alinity m 08N53-002

  real time Nucleic acid amplification system
  4 recalls950 reports
• Alinity m 09N78-095

  Reagents, 2019-novel coronavirus nucleic acid
  3 recalls357 reports
• Alinity m 09N79-096

  Reagents, 2019-novel coronavirus nucleic acid
  2 recalls179 reports
• Alinity m 09N78-03E

  Reagents, 2019-novel coronavirus nucleic acid
  3 recalls0 reports
• Alinity m 09N79-05D

  Reagents, 2019-novel coronavirus nucleic acid
  2 recalls0 reports
• Alinity m 09N78-085

  Reagents, 2019-novel coronavirus nucleic acid
  1 recall42 reports
• Alinity m 08N50-095

  Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
  1 recall1 report
• Alinity m 09N17-095

  Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
  1 recall1 report
• Alinity m 09N26-010

  real time Nucleic acid amplification system
  1 recall0 reports
• Alinity m 09N15-095

  KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
  1 recall0 reports
• Alinity m 09N43-095

  Nucleic acid amplification test for the quantitation of epstein-barr virus (EBV) DNA
  2 reports
• Alinity m 08N47-095

  Hepatitis Viral B DNA Detection
  1 report
• Alinity m 09N85-095

  Nucleic acid amplification test for the quantitation of BK virus (BK) DNA
  1 report

Recent Alinity m adverse event reports

The 15 most recent reports across all models, 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 23, 2026Low Test Results

  The customer reported a misquantitation low result while using the Alinity m BKV assay. The customer stated that their BKV results appear lower when compared to results obtained on another platform; however, they were unable to specify which platform was used for comparison. The customer also indicated that this situation is not considered a discrepancy at this time. The customer stated that the issue was not so much about any one questionable result, but rather an inquiry to demonstrate that the instrument and the assay are performing within expectations. The laboratory manager forwarded an email from the medical director of the Kidney Transplantation from (b)(6) 2026, in which it was stated they were "seeing a worrying trend with biopsy proven polyoma nephropathy with pretty low titers BK PCR performed at DLO/Quest labs (this site). There is a concern that the DLO/Quest PCR is not correlating well with other standard labs. A patient had biopsy proven polyoma nephropathy despite low titers BK PCR. JC PCR is negative. The patient was recently admitted to the hospital and had a BK PCR sent by mistake to ViraCor (another diagnostic company) and the titers were almost 7 times more tha

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872763 ↗
• 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 ↗

Other Abbott Molecular Inc. products

• RealTime4 models · 72 reports
• Vysis9 models · 10 reports · 1 recall