NUCLISENS® easyMAG® DisposablesRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03573026616618), received between Oct 23, 2017 and Jul 16, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  ON (B)(6) 2025, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A POTENTIAL CONTAMINATION WHEN USING NUCLISENS EASYMAG DISPOSABLE (REF. (B)(4) WITH EMAG (REF. (B)(4), SERIAL NUMBER: (B)(6). ON (B)(6) 2025, THE CUSTOMER PERFORMED THE EXTRACTION OF PATIENT SAMPLE (PLASMA) ON EMAG (SERIAL NUMBER: (B)(6). THE ELUATE WAS TESTED FOR BKV AND THE RESULT WAS POSITIVE (130656 IU/ML = 5.08 LOG10). TO BE NOTED THAT THIS RESULT IS HIGH (SAME LEVEL AS THE POSITIVE CONTROL OF THE RUN). INTERNAL CONTROLS OF EXTRACTION AND AMPLIFICATION WERE COMPLIANT. ON (B)(6) 2025, A SECOND EXTRACTION WAS PERFORMED OF THE SAME PATIENT SAMPLE AND A NEW ONE. THIS TIME, BOTH RESULTS WERE NEGATIVE FOR BKV. INTERNAL CONTROLS OF EXTRACTION AND AMPLIFICATION WERE COMPLIANT. THE CUSTOMER THEN REANALYZED THE EXTRACTED ELUATE ON (B)(6) 2025 AND AGAIN OBTAINED A POSITIVE RESULT COMPARABLE TO THE ORIGINAL (119820 IU/ML = 5.12 LOG10). THE EXTRACTION LOGS OF EMAG FOR ON (B)(6) 2025 WAS ANALYZED BY BIOMÉRIEUX GCS AND THE RUNS WERE COMPLIANT. THE ORDER OF SAMPLES IN THE RUN REPORT, FROM VESSEL TO OUTPUT TUBES WAS VERIFIED AND ARE STRICTLY IDENTICAL. DUE TO THIS ISSUE, THE CUSTOMER CLAIMED A DELAY OF A COUPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522133 ↗
• MalfunctionAug 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT INTERMITTENT LLS ERRORS IN ASSOCIATION WITH THE NUCLISENS® EASYMAG® DISPOSABLE VESSELS USED ON ONE OF THEIR EASYMAG® SYSTEMS. THE CUSTOMER REPORTED THAT RESULTS WERE DELAYED MORE THAN 24 HOURS WITH NO IMPACT TO PATIENT CARE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7802499 ↗
• MalfunctionMar 7, 2018Contamination; Leak/Splash; Contamination; Leak/Splash

  A CUSTOMER IN (B)(6) REPORTED A LEAKAGE PROBLEM WITH THE NUCLISENS® EASYMAG® DISPOSABLE (LOT Z109DN). THE CUSTOMER REPORTED THE FIRST WELL OF THE VESSEL WAS CRACKED AND THE SAMPLE LEAKED INTO THE EASYMAG INSTRUMENT. THERE IS NO INDICATION FROM THE LABORATORY THAT THE ISSUE LED TO DISCREPANT RESULTS OR ADVERSE EVENTS RELATED TO THE PATIENT, NOR ANY REPORT THAT THE LEAKING VESSEL LED TO ANY ADVERSE EVENTS RELATED TO THE USER; HOWEVER, THERE WAS UNEXPECTED LEAKAGE OF SAMPLE/REAGENT CONTENTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7320659 ↗
• MalfunctionFeb 23, 2018Contamination; Leak/Splash; Contamination; Leak/Splash

  A CUSTOMER IN (B)(6) REPORTED A LEAKAGE PROBLEM WITH THE NUCLISENS® EASYMAG® DISPOSABLE (LOT Z108GB). THE CUSTOMER STATED THEY OBSERVED A PERFORATION ON ONE DISPOSABLE VESSEL, AND THERE WAS LEAKAGE IN THE LAST WELL OF THE VESSEL. THE CUSTOMER COULD NOT CONFIRM IF OTHER VESSELS WERE AFFECTED, AS NOT ALL VESSELS WERE FILLED. THE CUSTOMER DISCARDED THE IMPACTED VESSEL AND NO LONGER HAD THE LOT. THERE IS NO INDICATION FROM THE LABORATORY THAT THE ISSUE LED TO DISCREPANT RESULTS OR ADVERSE EVENTS RELATED TO ANY PATIENT, NOR ANY REPORT THAT THE LEAKING VESSEL LED TO ANY ADVERSE EVENTS RELATED TO THE USER; HOWEVER, THERE WAS UNEXPECTED LEAKAGE OF SAMPLE/REAGENT CONTENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7294058 ↗
• MalfunctionFeb 23, 2018Contamination; Leak/Splash; Contamination; Leak/Splash

  A BIOMÉRIEUX EMPLOYEE REPORTED A PROBLEM WITH THE NUCLISENS® EASYMAG® DISPOSABLE (LOT Z108LC). THE EMPLOYEE REPORTED A LEAKAGE ISSUE WITH THE FIRST WELL OF THE VESSEL DURING EXTRACTIONS. THE CUSTOMER STATED OTHER VESSELS IN THE BATCH WERE NOT PIERCED. THERE WERE NO PATIENTS INVOLVED WITH THIS ISSUE. THERE IS NO INDICATION FROM THE LABORATORY THAT THE LEAKING VESSEL LED TO ANY ADVERSE EVENTS RELATED TO THE USER; HOWEVER, THERE WAS UNEXPECTED LEAKAGE OF SAMPLE/REAGENT CONTENTS.

  Patient problems: No Patient Involvement

  MAUDE report 7293605 ↗
• MalfunctionFeb 23, 2018Contamination; Leak/Splash; Contamination; Leak/Splash

  A CUSTOMER IN (B)(6) REPORTED A LEAKAGE PROBLEM WITH THE NUCLISENS® EASYMAG® DISPOSABLE (LOT Z108KC). THE CUSTOMER REPORTED RECEIVING ERROR CODES FOR THREE DISPOSABLE VESSELS, WHILE PERFORMING WHOLE BLOOD EXTRACTIONS. THE CUSTOMER STATED THERE WAS AN ERROR ON THE FIRST VESSEL AND DURING ANALYSIS OF THE SECOND VESSEL. THE CUSTOMER STATED THE FIRST VESSEL WAS REJECTED AND THE EXTRACTIONS WERE THEN OBTAINED USING WF5. THE PCR RESULTS WERE REPORTED AS MEETING EXPECTATIONS. LATER, THE CUSTOMER REPORTED THAT POSITION ONE (NEGATIVE CONTROL) LEAKED FROM ANOTHER VESSEL. THE CUSTOMER INDICATED THAT ALL THE ISSUES STARTED IN THE BEGINNING OF THE WEEK WITH THE LOT. THERE IS NO INDICATION FROM THE LABORATORY THAT THE ISSUE LED TO DISCREPANT RESULTS OR ADVERSE EVENTS RELATED TO THE PATIENT, NOR ANY REPORT THAT THE LEAKING VESSEL LED TO ANY ADVERSE EVENTS RELATED TO THE USER; HOWEVER, THERE WAS UNEXPECTED LEAKAGE OF SAMPLE/REAGENT CONTENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7292889 ↗
• MalfunctionOct 23, 2017Detachment Of Device Component; Device Operates Differently Than Expected; Missing Test Results; Detachment Of Device Component; Device Operates Differently Than Expected; Missing Test Results

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A PERFORMANCE ISSUE ASSOCIATED WITH NUCLISENS® EASY MAG® DISPOSABLE VESSEL ((B)(4)). THE CUSTOMER REPORTED THAT THE TIP WAS MISSING FROM THE CARTRIDGE AFTER RUN COMPLETION ON TWO (2) DIFFERENT EASYMAGS (EM 5 AND EM 9). ON BOTH OCCURRENCES, THE ISSUE WAS ON CARTRIDGE POSITION A THE SECOND TIP POSITION. AFTER THE RUNS COMPLETED, THE SECOND TIP FROM THE LEFT ON BOTH AFFECTED TIP CARTRIDGES WERE MISSING. THE CUSTOMER REPORTED THIS LEAD TO A DELAY IN REPORTING RESULTS LESS THAN 24 HOURS, AND THERE NO INDICATION OR REPORT THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6969078 ↗