FACSCantoRecalls & reported problems across all models

We found 4 models of FACSCanto by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 337 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2019 and Feb 6, 2026 — classified as 6 injuries, 331 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (151 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

FACSCanto recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 2, 2019Terminated

   A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It is released for research use only.

   Z-0792-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported FACSCanto problems

FACSCanto models

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

• FACSCanto 338960

  Counter, differential cell
  1 recall117 reports
• FACSCanto 338962

  Flow cytometric reagents and accessories.
  167 reports
• FACSCanto 657338

  Flow cytometric reagents and accessories.
  46 reports
• FACSCanto 339473

  Flow cytometric reagents and accessories.
  7 reports

Recent FACSCanto adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING FLUIDIC START-UP ON A BD FACSCANTO II FLOW CYTOMETER, A LEAK WAS IDENTIFIED. IN AN ERRORT TO STOP THE LEAK, THE USER DISCONNECTED A TUBE AT THE WET CART WHILE NOT WEARING SAFETY GLASSES, RESULTING IN FLUID SPRAYING INTO THEIR EYES. ADDITIONAL INFORMATION OBTAINED: WHILE THERE WAS AN INITIAL LIQUID LEAK DUE TO A COMPONENT FAILURE, THE DEFECTIVE COMPONENT WAS NOT ASSOCIATED WITH THE ALLEGED ADVERSE EVENT OF THE LIQUID SPRAY IN THE EYES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: INSTRUMENT LEAKAGE. 1. DID ANY LIQUID LEAKAGE OR SPLASH OR SPRAY COME INTO CONTACT WITH EYES OR MOUTH OR ANY MUCOUS MEMBRANE OR NON-INTACT (BROKEN) SKIN? IF NO, STOP, NO FURTHER QUESTIONS REQUIRED. YES. 2. PROVIDE THE FLUID THAT LEAKED OR SPLASHED OR SPRAYED: SHEATH. 3. WHICH PART OF THE BODY WAS IN CONTACT WITH THE FLUID? (PLEASE DESCRIBE THEN GO TO QUESTION #4): EYE. 4. WHAT PPE WAS BEING WORK? (PLEASE DESCRIBE) THE EYES WERE RISED INDEPENDENTLY, AND NO DISCOMFORT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284527 ↗
• MalfunctionDec 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II FLOW CYTOMETER ERRONEOUS RESULTS WERE REPORTED TO A CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6). 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? YES 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? YES 3. WAS THERE ANY CHANGE OR DELAY OF TREATMENT DUE TO THE ISSUE? NO BECAUSE THEY WILL RERUN THE SAMPLE ON THE SAME DAY AND NO DELAY FOR GENERATING THE CORRECT RESULTS ON TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778292 ↗
• MalfunctionAug 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II FLOW CYTOMETER A HIGHER CELL COUNT THAN WHAT WAS ACTUALLY PRESENT WAS REPORTED TO CLINICIAN. THE SAMPLE WAS RECOLLECTED THROUGH APHERESIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE COUNT DELIVERED WAS HIGHER THAN THEY EXPECTED. ADDITIONAL INFORMATION - THE PROBLEM WAS FOUND TO BE WITH THE INSTRUMENT (WHICH WAS REPORTED), NOT THE REAGENT AS ORIGINALLY THOUGHT AT TIME OF MDR SUBMISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690481 ↗
• MalfunctionJul 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ FLOW CYTOMETER PRODUCED ERRONEOUS FINAL LABORATORY RESULT FROM THE BD PRODUCT THAT WAS REPORTED TO A CLINICIAN. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FACSCANTO PLUS-UNSATISFACTORY SAMPLE RESULTS USING PATIENT SAMPLES, NOT SURE IF IT CAUSES HARM." MDR SAFETY CHECKLIST FOR PATIENT SAMPLES. 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. - YES. 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. - YES. MDR SAFETY CHECKLIST FOR CONTAMINATION. 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2.: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22399354 ↗
• MalfunctionMay 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II FLOW CYTOMETER ABNORMAL RESULTS WERE OBTAINED. NO PATIENT INJURY OR DELAY IN TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "CUSTOMER REPORTED 2 OF THEIR INSTRUMENTS ARE GIVING AN ABNORMAL RESULT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045907 ↗
• MalfunctionMar 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS AN INCORRECT RESULT WAS REPORTED OUT TO A PHYSICIAN. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY DECIDED TO RUN THE SAMPLES AFTER THE PASS WITH THE EXPIRED BEADS. THEY SHOULD NOT HAVE REPORTED THE RESULTS BECAUSE OF THE EXPIRED 7 COLOR SET UP BEADS, AND UNFORTUNATELY THE RESULTS WERE USED FOR INCLUSION/EXCLUSION IN A STUDY. CUSTOMER CONFIRMED THAT THERE WAS NO HARM, NEGATIVE IMPACT, OR INJURY TO THE PATIENT AS FAR AS THEY KNOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719506 ↗
• MalfunctionFeb 7, 2025Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX CALLED REPORTING A CARRYOVER PROBLEM WITH THIS INSTRUMENT. -CARRYOVER NOTICED ON A 2 SAMPLE RUN. IT WAS CAUGHT. NO FALSE REPORTING BASED ON THIS CARRYOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337680 ↗
• MalfunctionFeb 7, 2025Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART BLEACH MIXED WITH PATIENT SAMPLES WHICH IMPACTED PATIENT RESULTS. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT BLEACH IS GETTING INTO SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333368 ↗
• MalfunctionSep 12, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II FLOW CYTOMETER THE CUSTOMER GOT ELECTRICAL SHOCK. NO INJURY OR TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ELECTRICAL SHOCK FROM TOP OF CARROUSEL. NO INJURY TO PATIENT. INSTRUMENT SHUT OFF AND ISOLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201704 ↗
• MalfunctionMar 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH FACSCANTO¿ 10-COLOR CONFIGURATION CARRY OVER OCCURRED. THE ISSUE WAS DISCOVERED IN THE LAB AND ERRONEOUS RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX (FLOW CYTOMETRY MANAGER) REPORTED A SPINAL FLUID SAMPLE THEY RAN BECAME CONTAMINATED. THE SYSTEM OPERATOR DID NOT USE THE "REMOVE TUBE" COMMAND AND POSSIBLE DID NOT FULLY SWING THE ASPIRATOR TO THE LEFT TO INITIATE A SIP CLEANING CYCLE AFTER REMOVING THE PRECEDING SAMPLE. THE SYSTEM DID NOT SUFFICIENTLY CLEAN THE SYSTEM SAMPLE PROBE BEFORE RUNNING THE SPINAL FLUID. THE LAB HAS IMPLEMENTED ADDITIONAL STAFF TRAINING TO PREVENT A RE-OCCURRENCE. THE SPINAL FLUID SAMPLE APPEARED TO INDICATE A POSITIVE LEUKEMIA. INTERNAL LAB PROCEDURES AND CROSS CHECKING CAUGHT THE ISSUE BEFORE RESULTS WERE REPORTED. MDR SAFETY CHECKLIST -- CONTAMINATION: 1. WERE SAMPLES CONTAMINATED? YES. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? UNKNOWN. 3. IF PATIENT SAMPLES WERE RED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933620 ↗
• MalfunctionMar 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSCANTO¿ II FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.). YES. CLUSTERS NOT PROPER IN SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909055 ↗
• MalfunctionFeb 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER THAT BD FACSCANTO¿ II FLOW CYTOMETER SIP IS CLOGGED WITH ZERO EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK CHECKLIST SUMMARY: 1. DID ANY LIQUID LEAKAGE OR SPLASH OR SPRAY COME INTO CONTACT WITH EYES OR MOUTH OR ANY MUCOUS MEMBRANE OR NON-INTACT(BROKEN) SKIN? IF NO, STOP- NO FURTHER QUESTIONS REQUIRED: -NO. PATIENT SAMPLES CHECKLIST SUMMARY: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): -YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): UNKNOWN -YES. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): -NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): -NO. 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6): -PATIENT SAMPLES WERE NOT RELEASED. 6. WHAT IS THE CURRENT MEDICAL STATUS? NO FURTHER QUESTIONS REQUIRED: -PATIENT SAMPLES WERE NOT RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18812866 ↗
• MalfunctionFeb 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT LIQUID LEAKAGE OCCURRED ON BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD AND CAUSED ERRONEOUS PATIENT SAMPLE RESULTS. NO PATIENT TREATMENT DELAY WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIQUID LEAKAGE IN HYDRAULIC SYSTEM. ARE THERE ERRONEOUS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623673 ↗
• MalfunctionFeb 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSCANTO¿ II . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLE WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO ISSUE? NO. THE CUSTOMER REPORTED THE RESULTS ARE NOT AS EXPECTED. THE QC PASSED FINE. THE CUSTOMER DID SEVERAL CLEANINGS AND PURGES, BUT PROBLEM PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18620400 ↗
• MalfunctionJan 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USAGE OF BD FACSCANTO¿ II CARRYOVER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED 'WE HAVE THE SAME PROBLEM ON FACSCANTO II WITH CARRY OVER/CONTAMINATION OF THE INSTRUMENT. 1. WERE SAMPLES CONTAMINATED AS A CONSEQUENCE OF THIS ISSUE? YES 2. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES OR UNKNOWN ANSWER QUESTION 3) NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610710 ↗

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