ClearLLab 10C B96805Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590701475), received between Mar 25, 2022 and Oct 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED UNEXPECTED CD19+ EVENTS INTERMITTENTLY WHEN RUNNING CLEARLLAB ON THE NAVIOS EX 10 COLORS/3 LASER FLOW CYTOMETER. THE CUSTOMER REPORTED THAT THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH OR IMPACT TO PATIENT TREATMENT OR HEALTH. PATIENT RESULTS WITH QUESTIONABLE AND OR ABNORMAL SCATTER PATTERNS WERE RERUN WITH AN ALTERNATE METHOD. THE ISSUE IS NOT OCCURRING ON ALL SAMPLES. THE OTHER APPLICATIONS ARE RUNNING WITHOUT ISSUE ON THE SAME FLOW CYTOMETER. THE CUSTOMER USES THEIR OWN LABORATORY DEVELOPED SAMPLE PREPARATION PROCEDURE INSTEAD OF THE PROCEDURE IN THE INSTRUCTIONS FOR USE (IFU PN C00197). THE CLEARLAB TUBES WERE RUN ON THE NAVIOS EX 10 COLORS/3 LASER FLOW CYTOMETER: PART NUMBER: BB0910. SERIAL NUMBER: (B)(6). INSTRUMENT UDI: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877275 ↗
• MalfunctionMar 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE ARE USING CLEARLLAB 10C FOR CHARACTERIZATION B CELLS LEUKEMIA. CD38 MARKER IS DETECTED IN THE CHANNEL APC-AF700. WHEN WE SETUP THE COMPENSATION WITH THE PARAMETERS DEFINED BY MANUFACTUR THE SIGNAL IN CD38 APC AF700 IS SO HIGH AND THE EVENTS ARE SHOWN IN THE EXTREM E RIGHT AXIS. WE DETECT A SPECTRAL SPILLOVER BECAUSE THE PLASMA CELLS ARE POSITIVE IN THE NEXT CHANNEL WITH THE MARKER CD20 APC AF750. 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. THE CUSTOMER CONSIDERED THE RESULTS TO BE ERRONEOUS AND REPEATED THE TESTS USING LIQUID REAGENT TO OBTAIN ACCEPTABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13902717 ↗