Cytomics FC500 UPS (CXP)Recalls & reported problems
Beckman Coulter, Inc. · Cytomics FC 500 with CXP Software · Class 2
Quick summary
This Beckman Coulter Cytomics FC500 flow cytometer has 1,196 adverse event reports, with no deaths and 3 injuries. Most reports describe imprecise or incorrect readings, and some narratives mention electronic board errors and signal loss during startup quality checks. Some reports note that no erroneous patient results were found. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,196
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,196 adverse event reports that list this exact device (DI 15099590572839), received between Oct 26, 2018 and Nov 20, 2024 — classified as 3 injuries, 1,193 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1,190 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1,190
- Device Remains Activated1
- Electrical /Electronic Property Problem1
- Fire1
- Inadequate or Insufficient Training1
- No Apparent Adverse Event1
- Output Problem1
- Retraction Problem1
Patient problems
- No Consequences Or Impact To Patient1,005
- No Clinical Signs, Symptoms or Conditions190
- Test Result1
Recent adverse event reports
The 25 most recent of 1,196 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED ABNORMAL HISTOGRAMS ON THE FC500 FLOW CYTOMETER. THE FIELD SERVICE ENGINEER (FSE) FOUND THERE WAS A TARPON AMP BOARD ERROR AT FORWARD SCATTER (FS). THE EVENT OCCURRED DURING START THE FLOW CHECK (QUALITY CONTROL) RUN. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS ASSOCIATED WITH THE EVENT. THERE WAS NO REPORTED DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20738111 ↗MalfunctionJul 18, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE CUSTOMER REPORTED AMP BOARD ERRORS AT THE FL5 FLUORESCENCE CHANNEL ON THEIR FC500 FLOW CYTOMETER WHILE RUNNING FLOWCHECK AT START-UP. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PATIENT SAMPLES WERE NOT RUN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19778802 ↗MalfunctionJul 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERRORS AT THE FL5 FLUORESCENCE CHANNEL ON THEIR FC 500 FLOW CYTOMETER. 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 19776768 ↗MalfunctionMar 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED FL3 AND FL5 AMP BOARD ERRORS ON THEIR FC 500 FLOW CYTOMETER. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18944227 ↗MalfunctionJul 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED TARPON AMP BOARD ERRORS ON THE "FORWARD" SCATTER (FS), FL1 AND A FLOW CHECK SIGNAL DRIFT AT FL3 ON THEIR FC 500 FLOW CYTOMETER. 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 17364165 ↗MalfunctionJul 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED NO SIGNAL AT THE FL4 POSITION ON THEIR FC 500 FLOW CYTOMETER WHILE RUNNING FLOW CHECK. 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 17311809 ↗MalfunctionJun 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED FL4 PE TARPON AMP BOARD ERRORS ON THEIR FC 500 FLOW CYTOMETER. 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 17203053 ↗MalfunctionJun 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED INTERMITTENT SIGNAL LOSS FOR FL4 AND UNSTABLE SIGNAL FOR FL3 WHEN RUNNING FLOWCHECK ON THEIR FC 500 FLOW CYTOMETER. 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 17091997 ↗MalfunctionMay 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED FL1 AMP BOARD ERRORS ON THEIR FC 500 FLOW CYTOMETER WHILE RUNNING FLOW CHECK. 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 16887916 ↗MalfunctionApr 24, 2023Fire; Fire
THE CUSTOMER REPORTED HEARING A POPPING ELECTRICAL NOISE ON THEIR FC 500 FLOW CYTOMETER. THE UNIT (POWER SUPPLY CART) CAUGHT FIRE AS IT SAT IDLE. THE CUSTOMER REPORTED SEEING FLAMES THAT WERE PUT OUT WITH A FIRE EXTINGUISHER. THERE WAS NO DIRECT HARM TO LABORATORY OR LABORATORY PERSONNEL. 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 16799586 ↗MalfunctionApr 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED FL4 TARPON AMP BOARD ERRORS ON THEIR FC 500 FLOW CYTOMETER, WHILE PROCESSING BOTH FLOW CHECK AND QUALITY CONTROL. 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 16709296 ↗MalfunctionMar 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED INTERMITTENT FL4 X-MEAN SIGNAL SHIFT AND FL4 TARPON AMP BOARD ERRORS ON THEIR FC 500 FLOW CYTOMETER, WHILE PROCESSING BOTH FLOW CHECK AND QUALITY CONTROL. 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 16638285 ↗MalfunctionMar 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED TARPON AMP BOARD ERRORS AT THE FL3 AND SS (SIDE SCATTER) POSITION ON THEIR FC 500 FLOW CYTOMETER. 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 16512059 ↗MalfunctionJan 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERROR AT THE FLUORESCENCE CHANNELS (FL1,FL2,FL3, FL4 AND FL5) WHEN PROCESSING FLOW CHECK, QUALITY CONTROL. AND PATIENT SAMPLES ON THEIR FC500 FLOW CYTOMETER. 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 16099811 ↗MalfunctionJan 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT FLOWSET FLUORESCENCE CHANNEL ( FL1 AT 2%) AND FL1 HAS SHIFTED TO THE LEFT OF THE TARGETS WHEN RUNNING QUALITY CONTROL ON THEIR FC500 FLOW CYTOMETER. 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 16096901 ↗MalfunctionDec 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE FIELD SERVICE ENGINEER (FSE) REPORTED SIGNAL SHIFT AT FL2 AND FL3 POSITIONS ON THE FC500 FLOW CYTOMETER WHILE RUNNING FLOW CHECK CONTROL WHILE SERVICING THE INSTRUMENT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15982324 ↗MalfunctionDec 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A FORWARD SCATTER (FS) SIGNAL SHIFT ON THEIR FC 500 FLOW CYTOMETER. 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 15918797 ↗MalfunctionNov 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD WARNINGS AT THE FORWARD SCATTER (FS) POSITION OF THEIR FC 500 FLOW CYTOMETER. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS ASSOCIATED WITH THE EVENT. THERE WAS NO REPORTED DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15849488 ↗MalfunctionOct 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED INTERMITTENT SS AMP BOARD WARNING ON THEIR FC 500 FLOW CYTOMETER. 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 15654108 ↗MalfunctionOct 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED SIGNAL DRIFT AT THE FORWARD SCATTER (FS), AND FL5 POSITIONS ON THEIR FC 500 FLOW CYTOMETER WHILE RUNNING QUALITY CONTROL. 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 15594938 ↗MalfunctionSep 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE FSE REPORTED SIGNAL/PEAK SHIFTING AT THE FL2 AND FL3 WHEN RUNNING FLOW CHECK DURING A PM (PREVENTATIVE MAINTENANCE) ON THEIR FC 500 FLOW CYTOMETER. 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 15464578 ↗MalfunctionSep 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER THAT THE PLOTS ARE COMING OFF THE BASELINE AT THE FL2 POSITION OF THEIR FC 500 FLOW CYTOMETER. THERE WAS AN INTERMITTENT UPWARD SIGNAL SHIFT AT THE FL2 POSITION CAUSING ERRONEOUS RESULTS FOR THEIR LEUKEMIA/LYMPHOMA LDT. THE CUSTOMER DISCARDED THE RESULTS AND RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT TO OBTAIN CORRECT RESULTS. 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 15442246 ↗MalfunctionSep 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERRORS AT THE SS (SIDE SCATTER) POSITION ON THEIR FC 500 FLOW CYTOMETER WHEN RUNNING FLOW CHECK (CONTROL). 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 15420389 ↗MalfunctionSep 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A PROBLEM AT THE FL4 POSITION ON THE FC500 ON THEIR FC 500 FLOW CYTOMETER. 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 15414650 ↗MalfunctionAug 26, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE POPULATIONS AT THE FL4 POSITION ON THEIR FC 500 FLOW CYTOMETER WERE NOT BEING GATED CORRECTLY CAUSING ERRONEOUS CD34+ RESULTS. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. 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 15306968 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.