Navios 10 Color 3 lasersRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 15099590515522), received between Jan 25, 2018 and Oct 20, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Output Problem; Output Problem

  THE CUSTOMER REPORTED OBSERVING UNEXPECTED SCATTER PATTERNS FOR CD45+ VERSUS FORWARD SCATTER (FS) AND CD45 VERSUS SIDE SCATTER (SS), WHEN RUNNING THEIR LABORATORY DEVELOPED TEST (LDT) PROTOCOL ON THE NAVIOS 10 COLOR/3 LASER FLOW CYTOMETER. THE ISSUE WAS OBSERVED ON CD45 WHICH COULD POTENTIALLY IMPACT ANY OF THE CD MARKERS RUN ON ANY TEST PANEL. THE TEST RUNS WERE REJECTED AS INVALID AND RUN ON A SECOND INSTRUMENT WITH NO ISSUE. THERE WAS NO REPORT OF AN INJURY, DEATH, OR IMPACT ON TREATMENT OR DIAGNOSIS RELATED TO THE REPORTED ISSUE. THERE WERE NO REPORTS OF HARM TO A PATIENT, AN OPERATOR. THE USER FOLLOWED THE PUBLISHED INSTRUCTIONS AND DID NOT REPORT THE SUSPICIOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343880 ↗
• MalfunctionAug 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT CD10 WAS POSITIVE IN THE CLEARLLAB 10 C B-CELL TUBE, CD10 IN THE M1-TUBE AND CD2 IN THE CLEARLLAB T-TUBE ON THEIR NAVIOS FLOW CYTOMETER. HOWEVER, CD10 AND CD2 WERE NEGATIVE FOR ALL 6-COLOR ADD-ON TUBES THAT THE CUSTOMER USED TO CONFIRM THE POSITIVE TESTS. THESE RESULTS WERE OBTAINED ON A PERIPHERAL BLOOD SAMPLE FOR A PATIENT THAT PREVIOUSLY GENERATED SIMILAR RESULTS ON A BONE MARROW SAMPLE. ERRONEOUS PATIENT RESULTS WERE GENERATED BUT WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THIS ISSUE HAS ONLY OCCURRED ON THIS ONE PATIENT SAMPLE. NO OTHER PATIENT SAMPLE NOR CONTROLS HAVE EXHIBITED THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329419 ↗
• MalfunctionJul 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED POSITIVE CD10 IN THE CLEARLLAB 10 C B-CELL TUBE AND NEGATIVE CD10 IN THE M1-TUBE WHEN RUNNING IT ON THEIR NAVIOS FLOW CYTOMETER. THE B-CELL TUBE GENERATED POSITIVE RESULTS FOR CD10 COMPARED TO NEGATIVE RESULTS FROM THE M1-TUBE FROM THE SAME TEST PANEL FOR A BONE MARROW SPECIMEN. THIS ISSUE HAS ONLY OCCURRED ON THIS ONE PATIENT SAMPLE. NO OTHER PATIENT SAMPLE NOR CONTROLS HAVE EXHIBITED THE REPORTED ISSUE. ERRONEOUS PATIENT RESULTS WERE GENERATED BUT WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. TO CONFIRM THE CUSTOMER RAN A 6-COLOR ADD ON PROTOCOL. THE 6-COLOR ADD-ON TUBES HAD THE SAME CD10 CLONE, BUT IN DIFFERENT DYES (CD10-PE, CD10-APC, AND CD10-PC7). CD10 WAS NEGATIVE FOR ALL 6-COLOR ADD-ON TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236603 ↗
• MalfunctionJul 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED UNEXPECTED CD34 POSITIVITY ON FOUR CLEARLLAB 10C PATIENT SAMPLE TUBES REQUIRING SAMPLE PREPARATION TO BE REDONE. ERRONEOUS RESULTS WERE GENERATED BUT NOT REPORTED OUTSIDE OF THE LAB. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172844 ↗
• MalfunctionJul 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED UNEXPECTED CD34 POSITIVITY ON FOUR CLEARLLAB 10C PATIENT SAMPLE TUBES REQUIRING SAMPLE PREPARATION TO BE REDONE. ERRONEOUS RESULTS WERE GENERATED BUT NOT REPORTED OUTSIDE OF THE LAB. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172822 ↗
• MalfunctionApr 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED GETTING FREQUENT BLUE LASER WARNINGS AND UNEXPECTED MEAN VARIABILITY ON PATIENT SAMPLES THAT WERE RUN ON THE NAVIOS FLOW CYTOMETER. QUESTIONED RESULTS WERE GENERATED BUT NOT REPORTED OUT OF THE LAB. PATIENT SAMPLES WERE RERUN ON ANOTHER INSTRUMENT AND THOSE RESULTS WERE CONSIDERED CORRECT. THERE WAS NO REPORTED DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611446 ↗
• MalfunctionApr 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT LYMPHOMA CELLS FROM ONE SAMPLE APPEARED IN ANOTHER SAMPLE THAT WAS RUN SUBSEQUENTLY ON THE NAVIOS FLOW CYTOMETER. IT WAS DISCOVERED WHEN THE CUSTOMER RE-RAN A BATCH OF SAMPLES FOR AN UNRELATED REASON, AND FOUND THAT THE SAMPLE THAT PREVIOUSLY HAD LYMPHOMA CELLS NOW WAS COMPLETELY NEGATIVE. THE DISCREPANCY WAS DISCOVERED BEFORE THE TEST RESULT WAS RELEASED TO THE PHYSICIAN. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609426 ↗
• MalfunctionApr 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TETRACXP PATIENT PANEL RESULTS ALL POSITIONED IN QUADRANT 2 ON THEIR NAVIOS FLOW CYTOMETER. ERRONEOUS PATIENT RESULTS MAY HAVE BEEN GENERATED BUT WERE DISCARDED DUE TO CONTROL FAILURE. THERE WAS NO REPORTED DEATH, INJURY OR CHANGE TO PATIENT TREATMENT. THE CUSTOMER RUNS THE AUTO SETUP ONCE A WEEK AND USES THE SAME SETTINGS TO RUN SAMPLE CONTROLS AND PATIENT SAMPLES FOR THE WEEK. THE SAMPLE CONTROL FAILED. THE CUSTOMER DISCARDED THE RUN DATA AND DID NOT REPORT ANY PATIENT RESULTS. THE SAMPLES WERE RE-RUN ON A SECOND INSTRUMENT WITH NO ISSUE. EXAMPLE DATA WAS REQUESTED FROM THE CUSTOMER BUT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609424 ↗
• MalfunctionJun 7, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TETRA ALGORITHM FAILURES RELATED TO THE CAL REGION ON THE NAVIOS 10 COLORS/ 3 LASER FLOW CYTOMETER. ERRONEOUS PATIENT RESULTS MAY HAVE BEEN GENERATED BUT WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10126717 ↗
• MalfunctionJun 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE MIXER SOMETIMES STOPS ON THE NAVIOS 10 COLOR/3 LASER FLOW CYTOMETER. ERRONEOUS PATIENT RESULTS WERE GENERATED BUT NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10120223 ↗
• InjurySep 19, 2019Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT THEIR NAVIOS FLOW CYTOMETER SYSTEM WAS GENERATING SHEATH/WASTE OVERFLOW ERRORS. IN AN ATTEMPT TO TROUBLESHOOT, THE OPERATOR TRIED TO EMPTY THE WASTE CHAMBER WITH A SYRINGE AND A TUBING POPPED OFF SPLASHING A SMALL AMOUNT OF FLUID INTO THE EYE OF THE OPERATOR. THE OPERATOR WAS WEARING ONLY GLOVES AS THEIR PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE INCIDENT. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. MEDICAL INTERVENTION WAS NO REQUIRED, ONLY SEROLOGICAL TESTING WAS PERFORMED AS REQUIRED BY THE FACILITY EXPOSURE PLAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9090247 ↗
• MalfunctionJan 25, 2018Fire; Fire

  THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR THE DATA INNOVATION PC OF THEIR NAVIOS INSTRUMENT CAUGHT FIRE. THERE WAS A CONTAINED FIRE AND SMOKE REPORTED. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THE EVENT. MEDICAL ATTENTION WAS NOT REQUIRED BY ANYONE INVOLVED IN THE EVENT. THE FIRE DEPARTMENT WAS CALLED BUT UPON THEIR ARRIVAL THERE WAS NO LONGER A FIRE. A FIRE EXTINGUISHER WAS NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7220569 ↗