Navios EX 10 Color 3 lasersRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15099590677466), received between Jan 30, 2020 and Dec 29, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ERRONEOUS/QUESTIONABLE WERE GENERATED ON THE NAVIOS EX 10 COLORS/3 LASERS FLOW CYTOMETER WHEN RUNNING A CUSTOMER DEVELOPED LEUKEMIA/LYMPHOID PANEL. NON-SPECIFIC STAINING WAS OBSERVED WHICH RESULTED IN VARIABILITY FROM TUBE TO TUBE FOR THE THREE-TUBE PANEL TEST. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422069 ↗
• MalfunctionOct 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED SAMPLES SHOW UNUSUAL PATTERNS ON THE NAVIOS EX 10 COLORS/3 LASER FLOW CYTOMETER DUE TO A BROKEN SHEATH HARNESS. THE RESULTS WERE REJECTED AS QUESTIONABLE/ERRONEOUS DUE TO THE HISTOGRAM PATTERNS. THE CUSTOMER WAS RUNNING A LABORATORY DESIGNED TEST (LDT). THERE WERE QUESTIONABLE PATIENT RESULTS GENERATED BUT NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO ADVERSE EVENT, CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THE RESULTS WERE REJECTED AS QUESTIONABLE/ERRONEOUS DUE TO THE HISTOGRAM PATTERNS. THE CUSTOMER WAS RUNNING A LABORATORY DESIGNED TEST (LDT). THE DATA PROVIDED BY THE CUSTOMER CONFIRMS THE UNUSUAL HISTOGRAM PATTERNS. THIS PATTERN COULD BE INTERPRETED AS A FALSE NEGATIVE OR GENERATE AN ERRONEOUS VALUE. THE CUSTOMER FOLLOWED LABELING INSTRUCTIONS AND CALLED TO REPORT THE ISSUE. THE POTENTIALLY ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY QUALITY CONTROL WAS WITHIN SPECIFICATIONS. THE ISSUE MANIFESTED AFTER THE QC RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911689 ↗
• MalfunctionSep 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT CD45 POPULATIONS LOOKED ABNORMAL WHEN RUNNING THEIR LABORATORY DESIGNED APPLICATION ON THE NAVIOS EX 10 COLORS/3 LASER FLOW CYTOMETER. THREE (3) PATIENTS, WITH 4 TUBES IN THE PANEL, ALL HAD THE FS (FORWARD SCATTER) CUT OFF AND THE MONOS/GRANS FALLING IN THE DIM CD45 POPULATION AREA. THE CUSTOMER CONFIRMED THAT ONE ERRONEOUS SAMPLE RESULT WAS REPORTED OUT OF THE LABORATORY DUE TO CD34 NEGATIVE WITH A CD33 POSITIVE RESULTS. THE CUSTOMER STATED THAT ERRONEOUS RESULTS WERE REPORTED OUT AS SUSPECTED APML (ACUTE PROMYELOCYTIC LEUKEMIA) BUT NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE ERRONEOUS RESULTS. ONCE THE ISSUE WAS IDENTIFIED, THE SAMPLE WAS RE-RUN TWICE WITH CONFIRMING NEGATIVE APML RESULTS. THERE WAS NO REPORTED DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418236 ↗
• MalfunctionOct 27, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT CLEARLAB 45 POPULATION WAS TOO BRIGHT ON ALL LOST AND ALL 4 TUBES, AND WAS NOT ABLE TO DISTINGUISH CD NEGATIVE, MODERATE, BRIGHT AT THE FL10 POSITION ON THE NAVIOS EX INSTRUMENT. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LAB. THERE WAS NO REPORT DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708852 ↗
• MalfunctionMay 27, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED UNEXPECTED POSITIVE (HIGH) RESULTS FOR CD138 ON THEIR NAVIOS EX FLOW CYTOMETRY INSTRUMENT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897783 ↗
• MalfunctionJan 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED GETTING LOW LYMPHOCYTE COUNT ON THEIR NAVIOS EX FLOW CYTOMETER SYSTEM. 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. THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649898 ↗