Cytomics FC500Recalls & reported problems across all models

We found 2 models of Cytomics FC500 by Beckman Coulter, Inc. in the FDA's device registry (GUDID). Together they are named in 1,337 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2018 and Nov 20, 2024 — classified as 4 injuries, 1,333 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1,330 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Cytomics FC500 problems

Cytomics FC500 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cytomics FC500 UPS (CXP)

  Counter, Differential Cell
  1,196 reports
• Cytomics FC500 UPS (MPL)

  Counter, Differential Cell
  141 reports

Recent Cytomics FC500 adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗

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