Cytomics FC500 UPS (MPL)Recalls & reported problems
Beckman Coulter, Inc. · Cytomics FC 500 MPL with MXP Software · Class 2
All models of Cytomics FC500 (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Beckman Coulter Cytomics FC500 is a lab flow cytometer that analyzes cells in blood and other samples. Its 141 reports mostly describe incorrect readings caused by board errors and signal drift, and most say no patient consequences were reported. There are no deaths and 1 injury. 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
- 141
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 15099590572822), received between Sep 5, 2018 and Apr 28, 2023 — classified as 1 injury, 140 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (140 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
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings140
- Sharp Edges1
Patient problems
- No Consequences Or Impact To Patient120
- No Clinical Signs, Symptoms or Conditions20
- Head Injury1
Recent adverse event reports
The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERRORS AT THE FOLLOWING FLUORESCENCE CHANNELS (FL2, FL3 AND FL4) POSITIONS ON THEIR FC500, WHILE RUNNING 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 16833605 ↗MalfunctionSep 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED INTERMITTENT SIGNAL DRIFT AT THE FL5 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 15374253 ↗MalfunctionJan 18, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED SIGNAL DRIFT AT FL1 POSITION ON THEIR FC 500 MPL 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 13286997 ↗MalfunctionDec 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERROR AT THE FL1 AND FL4 POSITIONS 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 13006594 ↗MalfunctionNov 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
WHILE AT THE CUSTOMER'S SITE FOR AN UNRELATED ISSUE, THE FSE REPORTED THAT THE FC 500 FLOW CYTOMETER WAS GENERATING AN INTERMITTENT SIGNAL AT THE SIDE SCATTER (SS) CHANNEL LOCATION. 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 12849476 ↗MalfunctionNov 12, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A WEAK SIGNAL AT THE SIDE SCATTER (SS) CHANNEL LOCATION OF 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 12805038 ↗MalfunctionNov 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
WHILE AT THE CUSTOMER SITE PERFORMING PREVENTIVE MAINTENANCE ON THE CUSTOMER'S FC 500 FLOW CYTOMETER, THE FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE TARPON AMP BOARDS AT THE FL3 AND FL4 WERE GENERATING ERRORS. 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 12791767 ↗MalfunctionNov 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERRORS AT THE FL4 POSITION WHILE RUNNING FLOW CHECK 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 12791755 ↗MalfunctionOct 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE FIELD SERVICE ENGINEER (FSE)REPORTED INSTABILITY OF THE FL1 SIGNAL DURING A SERVICE VISIT FOR THE CUSTOMER'S 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 12566668 ↗MalfunctionSep 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED UNSTABLE FLOW COUNT RATES (FCRS) ON THEIR FC 500 FLOW CYTOMETER. ERRONEOUS PATIENT RESULTS WERE GENERATED BUT WERE NOT REPORTED OUT OF THE LABORATORY. THE AMP BOARD FAILURE CAUSED THE NEGATIVE POPULATION TO BE PLACED IN THE WRONG POSITION ON THE HISTOGRAM. THERE WAS NO REPORTED DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12419091 ↗MalfunctionAug 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERRORS AND WARNINGS AT THE FL4 POSITION WHEN RUNNING FLOW CHECK 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 12340425 ↗MalfunctionAug 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERRORS AT THE FL2 AND FL5 CHANNEL POSITIONS OF 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 12340394 ↗MalfunctionAug 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
WHILE DOING PREVENTIVE MAINTENANCE ON THE CUSTOMER'S FC 500 FLOW CYTOMETER, THE FIELD SERVICE ENGINEER (FSE) OBSERVED A MALFUNCTIONING TARPON AMP BOARD AT THE FL3 LOCATION. 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 12278654 ↗MalfunctionJun 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED TARPON AMP BOARD ERRORS AT THE FL3 LOCATION OF THEIR FC 500 FLOW CYTOMETER. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. COULTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11996935 ↗MalfunctionJun 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERRORS AT THE FL2, FL3 AND FL4 POSITIONS AND WARNINGS AT THE FORWARD SCATTER (FS) AND FL1 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 11972083 ↗MalfunctionApr 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD ERRORS AT THE FL2 POSITION OF 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 11619117 ↗MalfunctionMar 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
WHILE ON SITE FOR AN UNRELATED SERVICE VISIT, THE FIELD SERVICE ENGINEER (FSE) OBSERVED TARPON AMP BOARD FAILURES ON THE CUSTOMER'S 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 11467185 ↗MalfunctionJan 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A WEAK SIGNAL AT THE FL1 CHANNEL OF 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 11244935 ↗MalfunctionJan 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED AMP BOARD SIGNAL DRIFTING AT THE FS, FL1, FL2, FL3 AND FL4 POSITIONS OF 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 11207744 ↗MalfunctionJan 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED TARPON AMP BOARD ERRORS AT THE SS (SIDE SCATTER) LOCATION 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 11150594 ↗MalfunctionSep 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED SIGNAL DRIFTING IN THE FS, FL1, AND FL3 LOCATIONS 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 Consequences Or Impact To Patient
MAUDE report 10610794 ↗MalfunctionJul 27, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED TARPON AMP BOARD ERRORS AT THE FL3 POSITION OF 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 Consequences Or Impact To Patient
MAUDE report 10329660 ↗MalfunctionJul 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED GATING ISSUES WHEN RUNNING CD4 PLG 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 Consequences Or Impact To Patient
MAUDE report 10268146 ↗MalfunctionJun 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED A FAULTY SIGNAL AT THE FL4 PE CHANNEL LOCATION ON THE CUSTOMER'S 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 Consequences Or Impact To Patient
MAUDE report 10193093 ↗MalfunctionJun 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE FIELD SERVICE ENGINEER (FSE) OBSERVED FAULTY SIGNAL AT THE FL3 LOCATION OF 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 Consequences Or Impact To Patient
MAUDE report 10190996 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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