m2000 9K15-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884999031814), received between Mar 15, 2018 and Nov 15, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (4 reports).

7 other recalls cover devices cleared under the same FDA submission (K092705); 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023False Positive Result; False Positive Result

  THE CUSTOMER GENERATED FALSELY POSITIVE RESULTS WHEN USING THE REALTIME M2000RT INSTRUMENT. THE CUSTOMER IS USING A LAB-DEVELOPED ASSAY (LDA) WHICH TESTS FOR BKV. SPECIFICALLY, THE CUSTOMER NOTED THAT THE QUESTIONED RESULTS WERE GENERATED BY THE INSTRUMENT ON OCTOBER 5 AND OCTOBER 13. IT WAS NOTED THAT NON-SIGMOIDAL AMPLIFICATION CURVES WERE OBSERVED. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2023 SID (B)(6) RESULTED AS POS WITH CN VALUE16.77, REPEATED (B)(6) 2023 NEGATIVE (B)(6) 2023 SID (B)(6) RESULTED AS POS WITH CN VALUE15.81, REPEATED (B)(6) 2023 NEGATIVE (B)(6) 2023 SID (B)(6) RESULTED AS POS WITH CN VALUE 15.61, REPEATED (B)(6) 2023 NEGATIVE (B)(6) 2023 SID (B)(6) RESULTED AS POS WITH CN VALUE 38.3, REPEATED (B)(6) 2023 NEGATIVE (B)(6) 2023 SID (B)(6) RESULTED AS POS WITH CN VALUE 31.48 , REPEATED (B)(6) 2023 NEGATIVE IT WAS NOTED THAT THE CUSTOMER USES TWO SETS OF ASSAY CONTROLS ON EACH RUN OF THIS LAB-DEVELOPED ASSAY, BOTH SETS WORKED AS EXPECTED ON THE RUNS IN QUESTION. NO ERROR CODES WERE GENERATED FOR THE RESULTS WITH THIS LAB-DEVELOPED ASSAY. AN ABBOTT FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE COMPLETED REPLACEMENT OF THE LAMP SO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140025 ↗
• MalfunctionJul 29, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON THE REALTIME SARS-COV-2 ASSAY. THE CUSTOMER REPORTED THAT THE PATIENT WAS TESTED FOR SARS-COV-2 AS HE WAS ABOUT TO ENTER THE HOSPITAL. THE PATIENT WAS NOT EXPECTED TO BE POSITIVE FOR SARS-COV-2. THE RESULT WAS AUTOMATICALLY REPORTED TO THE PHYSICIAN WITHOUT ANY FURTHER REVIEW. THE DOCTOR QUESTIONED THE RESULT. THE PATIENT WAS ABOUT TO BE TRANSFERRED TO ANOTHER HOSPITAL, HOWEVER, THAT HOSPITAL DENIED THE PATIENT DUE TO THE POSITIVE SARS-COV-2 RESULT. A SECOND SAMPLE WAS TAKEN, AND THAT RESULT WAS NEGATIVE. THE CUSTOMER CHECKED THE AMPLIFICATION CURVES AND SAW THAT SHAPE WAS NON-SIGMOIDAL, LIKELY ARTIFICIAL, AND THUS, FALSE POSITIVE. THE INITIAL AND SECOND SAMPLE WERE ALSO TESTED ON ANOTHER SYSTEM AND BOTH RESULTS WERE NEGATIVE. THE PATIENT HAD SYMPTOMS OF CARDIAC DISEASE AND WAS IN THE HOSPITAL FOR CARDIAC INVESTIGATION. THE PATIENT WAS TO BE MOVED TO ANOTHER HOSPITAL FOR TREATMENT, BUT DUE TO THE DISCREPANT RESULT, THE MOVE WAS DELAYED BY APPROXIMATELY 48 HOURS. THERE WAS A DELAY IN PATIENT TREATMENT AS THE PATIENT COULD NOT BE TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER DIAGNOSTICS AND TREATMENT DUE TO THE POSITIVE SARS-COV-2 RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130639 ↗
• MalfunctionJul 22, 2022False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE REALTIME SARS COV-2 ASSAY. CUSTOMER REPORTED IN 21 FALSE POSITIVE RESULTS WHICH WERE INITIALLY POSITIVE BUT WERE NEGATIVE WHEN REPEATED ON AN ALINITY M INSTRUMENT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THE SAMPLES WERE A BATCH OF RESPIRATORY SWABS SENT IN AS PART OF PREOPERATIVE SCREENING. THE REANALYSIS WAS TRIGGERED BY ONE OF THE RESULTS BEING RELATED TO AN UPCOMING SURGERY, WHICH WAS THEN RETESTED ON ALINITY M AND CAME OUT NEGATIVE. DUE TO THIS, THE CUSTOMER MORE CLOSELY EVALUATED THE CURVES OBTAINED ON THEIR M2000RT AND ENCOUNTERED "JAGGED FLUORESCENT SIGNAL WITH VERY LOW FLUORESCENCE" THAT DID NOT LOOK LIKE REAL POSITIVE RESULTS. AS A CONSEQUENCE, THE CUSTOMER RETESTED ALL 21 POSITIVES OF THE M2000RT PLATE AND THEY ALL WERE NEGATIVE ON ALINITY. THE POSITIVE RESULTS OBTAINED BY THE LAB WERE COMMUNICATED TO THE DOCTORS ON (B)(6), AND THEN AMENDED TO NEGATIVE FOLLOWING THE ALINITY ANALYSIS ON (B)(6). NO IMPACT TO PATIENT MANAGEMENT HAS BEEN DECLARED AS A CONSEQUENCE, AS THE UPCOMING SURGICAL PROCEDURE WAS NOT COMPROMISED IN THE END. DURING THE COMPLAINT INVESTIGATION PERFORMED IN ASSOCIATION WITH MDR 3005248192-2021

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089853 ↗
• MalfunctionFeb 9, 2021False Positive Result; False Positive Result

  CUSTOMER REPORTED THAT THE LAMP FOR THEIR M2000RT INSTRUMENT WAS NOT SITTING PROPERLY RESULTING IN ERRONEOUS RESULTS WHEN RUNNING THE REALTIME SARS COV-2 ASSAY. WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY, THE CUSTOMER HAD A FEW SAMPLES WHICH GENERATED POSITIVE RESULTS BUT HAD UNEXPECTED GRAPHS. WHEN THE CUSTOMER REALIZED THAT THE GRAPHS LOOKED UNNATURAL, THEY REPEATED THE SAMPLES IN ANOTHER M2000RT INSTRUMENT, WHICH GENERATED NEGATIVE RESULTS. CUSTOMER REPORTED THESE SAMPLES AS NEGATIVE; THEREFORE, SUSPECT RESULTS WERE NOT RELEASED TO HAVE ANY IMPACT TO PATIENT MANAGEMENT. OTHER SAMPLES RUN ON THIS RUN, THAT DID NOT HAVE ENOUGH SAMPLES TO RERUN AND CONFIRM WERE REPORTED AS UNDETERMINED. MOLECULAR APPLICATION SPECIALIST (MAS) PERFORMED LOGFILE ANALYSIS THAT REVEALED THE SAMPLES HAD A SHAKY REFERENCE SIGNAL WHICH CAUSED THE RESULTS TO BE CALLED POSITIVE. MAS ASKED THE CUSTOMER TO CHECK THE LAMP, AND CUSTOMER CONFIRMED THAT THE LAMP WAS NOT SITTING PROPERLY. CUSTOMER PLACED THE LAMP IN ITS POSITION AND REPEATED THE CALIBRATION. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING THE M2000RT INSTRUMENT, 9K15-01, WHICH IS REGISTERED IN THE UNITED STATES,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300518 ↗
• MalfunctionMar 22, 2018Fire; Fire

  THE ABBOTT M2000 REALTIME SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR TO PROVIDE QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. CUSTOMER REPORTED THEY SMELLED SOMETHING BURNT FROM AN UN-KNOWN SOURCE AND CALLED THE HOUSE ELECTRICIAN. WHEN HE ARRIVED A FEW MINUTES LATER THERE WAS LOTS OF SMOKE COMING OUT OF THE M2000RT INSTRUMENT AND SHORTLY AFTER THEY SAW FLAMES AS WELL FROM THE HEATER BLOCK AREA WHILE IT WAS RUNNING. THEY USED A FIRE EXTINGUISHER AND KILLED THE FLAMES. THE CUSTOMER UNPLUGGED THE INSTRUMENT FROM THE POWER SOCKET AND THE SMOKE FORMATION STOPPED. NO ONE WAS INJURED AND THERE WAS NO VISIBLE DAMAGE EXTERNAL TO THE M2000RT INSTRUMENT. ENGINEER WAS DISPATCHED. AN ELEVATED COMPLAINT INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. ACCORDING TO THE CURRENT VERSION OF ADVERSE EVENT REPORTING PROCEDURE, AM23-01-002, THIS ISSUE MEETS THE CRITERIA FOR AN MDR "ALWAY

  Patient problems: No Patient Involvement

  MAUDE report 7361667 ↗
• MalfunctionMar 15, 2018Use of Device Problem; Use of Device Problem

  CUSTOMER WITNESSED AN ELECTRICAL SPARK WHEN SHE DROPPED A PAPER CLIP INTO A HOLE IN THE TOP OF THE UNINTERRUPTIBLE POWER SUPPLY (UPS) USED WITH THEIR M2000RT INSTRUMENT. CUSTOMER STATED THAT SHE WAS TALKING TO MOLECULAR APPLICATION SPECIALIST (MAS) AND PLACING A PARTIALLY STRAIGHTENED PAPER CLIP NEAR AN OPEN HOLE ON TOP OF THE UPS. CUSTOMER STATED SHE ACCIDENTALLY DROPPED THE STRAIGHT PART OF THE PAPER CLIP INTO THE HOLE CAUSING THE SPARK. CUSTOMER DID CONFIRM THAT SHE DROPPED THE PAPER CLIP INTO THE HOLE ON TOP WHERE A STOPPER OR PLUG SHOULD HAVE BEEN. MAS ASKED CUSTOMER ABOUT WHEN THE STOPPER OR PLUG WAS REMOVED, BUT CUSTOMER CANNOT RECALL WHEN OR HOW THAT STOPPER WAS REMOVED. CUSTOMER STATED THAT THE PAPER CLIP FALLING ONTO THIS SECTION CAUSED AN ELECTRICAL SPARK AND THEN A SMALL AMOUNT OF SMOKE FROM THE SPARK. CUSTOMER CONFIRMED THAT SHE WAS NOT INJURED OR SHOCKED DURING THE INCIDENT. CUSTOMER CONFIRMED THAT NO FIRE STARTED FROM THE ELECTRICAL SPARK. CUSTOMER STATED THAT SHE COULD SMELL THE SMOKE FROM THE ELECTRICAL SPARK. MAS INSTRUCTED THE CUSTOMER TO IMMEDIATELY POWER EVERYTHING DOWN AND UNPLUG THE UPS AND EVERYTHING PLUGGED INTO THE UPS. MAS ALSO INSTRUCTED CUSTOMER TO PLUG

  Patient problems: No Patient Involvement

  MAUDE report 7343830 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092705. One submission often covers many models, so check the product and lot details in each record.

• Z-0463-2015 · Oct 23, 2014 · Terminated
  Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
• Z-2169-2014 · Jun 19, 2014 · Terminated
  5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplific
• Z-0948-2015 · Nov 23, 2013 · Terminated
  The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
• Z-0634-2013 · Dec 4, 2012 · Terminated
  Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m
• Z-2013-2012 · Jan 31, 2012 · Terminated
  Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc
• Z-0365-2012 · Oct 11, 2011 · Terminated
  Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14
• Z-0048-2012 · Sep 8, 2011 · Terminated
  Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott M