FACSCanto 338960Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00382903389605), received between Apr 6, 2020 and Feb 6, 2026 — classified as 2 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (51 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 117 reports, 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 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionJan 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USING BD FACSCANTO¿ II FLOW CYTOMETER ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE WITH SAMPLE FLOW. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, 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) NO, CLIENT USED BACK-UP SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610708 ↗
• MalfunctionJan 19, 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 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? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. PLOT NOT CORRECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548156 ↗
• MalfunctionDec 29, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD FAILED TO START UP. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS ERROR HAPPENED ON STARTUP. CUSTOMER HAD COMPLETED A LONG CLEAN ON THE INSTRUMENT, BUT IT STILL FAILS, WET CART PRESSURE APPEARS TO BE LOW. REQUESTING FSE ONSITE TO REPAIR. CUSTOMER STATED THAT SHE CAN HEAR AN ODD NOISE WHEN STARTING THE SYSTEM AND SHE IS GETTING AN E011 ERROR." "MDR SAFETY CHECKLIST - ERROR MESSAGES (CASE): 1. IS THIS FACSPRESTO OR FACSCOUNT? IF YES, NO FURTHER QUESTIONS REQUIRED. IF NO, GO TO QUESTION #2.:NO. 2. DID THE INSTRUMENT DISPLAY AN ERROR MESSAGE? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.:YES. 3. WERE PATIENT SAMPLES RUN ON THE INSTRUMENT AFTER AN ERROR MESSAGE WAS DISPLAYED? IF YES, GO TO PATIENT SAMPLES CHECKLIST. IF NO, NO FURTHER QUESTIONS REQUIRED.:YES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18421982 ↗
• MalfunctionDec 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER USING BD FACSCANTO¿ II FLOW CYTOMETER ERROR MESSAGE WAS BYPASSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 4. IS THIS PRESTO ? NO. IT WAS REPORTED BY THE CUSTOMER THAT ERROR E060- LOAD UNLOAD DETECTION ERROR. ERROR IS HAPPENING INTERMITTENTLY, CYTOMETER WILL DISCONNECT AFTER THE ERROR AND IF THE ERROR IS NOT CAUGHT, THE WHOLE SAMPLE WILL BE ASPIRATED. CUSTOMER TRIED REBOOTING AND ISSUE PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303165 ↗
• MalfunctionOct 31, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD WASTE TANK FULL ERROR OCCURRED WHILE RUNNING PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE TANK FULL ERROR ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST?: (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.):YES. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. DID THE CUSTOMER BYPASS THE ERROR MESSAGE?: (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040288 ↗
• MalfunctionOct 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD SENSOR ERROR CAME ON WHILE RUNNING PATIENT SAMPLES AND ERROR WAS BYPASSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE SENSOR ERROR. 1.ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? ANS. YES. 2. WAS THERE AN ERROR MESSAGE?. ANS. YES. 3.DID THE CUSTOMER BYPASS THE ERROR MESSAGE? ANS. YES. 4.IS THIS PRESTO? ANS. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17991315 ↗
• MalfunctionOct 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING CONTINUED DURING USE WITH THE BD FACSCANTO¿ II FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT ERROR E009 - FLOAT SWITCH TIMEOUT OCCURS WHEN PERFORMING THE LONG CLEAN. THE CUSTOMER STATED THAT SHE COULD BLEED THE BLEACH AND WATER FILTERS. SHE COULD NOT TROUBLESHOOT BECAUSE SHE HAD A LOT OF SAMPLES TO RUN. EMAIL: CUSTOMER IS REPORTING AN ERROR E009 - FLOAT SWITCH TIMEOUT WHEN PERFORMING THE LONG CLEAN. MDR SAFETY CHECKLIST -- ERROR MESSAGES. 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED: YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED: YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED: YES. 4. IS THIS PRESTO? (EITHER YES OR NO, NO FURTHER QUESTIONS REQUIRED): NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906539 ↗
• MalfunctionOct 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING WAS ABLE TO CONTINUE DURING USE WITH THE BD FACSCANTO¿ II FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT FLOAT SWITCH TIME OUT MESSAGE ONLY WHEN PERFORMING A LONG CLEAN. ERROR MESSAGE CHECKLIST: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. 2. WAS THERE AN ERROR MESSAGE? YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? YES. 4. IS THIS PRESTO? NO. PATIENT SAMPLE CHECKLIST: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. IS INSTRUMENT ASSURITY LINC ENABLED? UNKNOWN. CUSTOMER PROBLEM: FLOAT SWITCH TIME OUT MESSAGE ONLY WHEN PERFORMING A LONG CLEAN. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: TALKED WITH CX. FLOAT SWITCH TIME ONLY OCCURS WHEN PERFORMING A LONG CLEAN SCRIPT. FLUIDIC STARTUP AND SHUT DOWN COMPLETES WITHOUT ISSUES. TUBING UP TO THE FACS CLEAN CAPSULE FILTER IS FULL OF AIR AND CAPSULE FILTER WON'T BLEED OF AIR. FACS: CLEAN PROBE TUBING HAS AIR INSIDE AND WON'T MOVE OUT WITH "PRIME AFTER TANK REFILL" COMMAND. INSPECTION OF FEMALE BULKHEAD CONNECTOR SHOWS IT IS BROKEN INSIDE. FACS: CLEAN FEMALE BULKHEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906440 ↗
• MalfunctionJul 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULTS. FACSCANTO II - INACCURATE TEST RESULTS. NO HARM CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276257 ↗
• MalfunctionMay 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WERE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES? YES. RESULTS INCOMPATIBILITY, DOES NOT REPRODUCE, RESULTS OF THE SAME SAMPLE CHANGE IF RUN 2 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873594 ↗
• MalfunctionApr 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE ERRONEOUS RESULTS ON PATIENT SAMPLES. THERE WAS NO DELAY OF ANY TREATMENT DUE TO THIS ISSUE. THERE WAS NO CHANGE OR DELAY OF TREATMENT. THERE WAS NO PHYSICAL HARM OR INJURY TO A PATIENT AS A RESULT OF THIS ISSUE. NO SEPARATION ON BONE MARROW SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716106 ↗
• MalfunctionMar 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCANTO¿ II FLOW CYTOMETER ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. 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 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) NO 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, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO CUSTOMER REPORTED UNSATISFACTORY SAMPLE LOADING RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503717 ↗
• MalfunctionFeb 27, 2023Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II FLOW CYTOMETER THAT THERE WAS AN ERROR MESSAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY WERE RECEIVING ERRORS MESSAGES BUT THAT THEY WERE ABLE TO CONTINUE AND RUN SAMPLES, RUN FLUIDIC STARTUP BUT STARTING TODAY THE ERRORS BECAME NUMEROUS : LOW BLUE LASER POWER,LOW RED LASER POWER, FLUIDICS BOARD REQUEST SHUTDOWN , BISH SWITCH TIMEOUT AND THEY WERE UNABLE TO GET THRU FLUIDICS STARTUP THEY WERE FAILING FLUIDICS STARTUP. I ASKED THE CUSTOMER TO VERIFY WETCART PRESSURE AND THEY STATED THAT WETCART PRESSURE WAS 35PSI. I ASKED THE CUSTOMER TO DISCONNECT THE AIR OUT LINE FROM THE WETCART . THE CUSTOMER DISCONNECTED THE LINE AND THE PSI JUMPED TO 70 PSI. I THEN ASKED THE CUSTOMER TO OPEN THE RIGHT PANEL OF THE CYTOMETER AND THEN RECONNECT THE AIR LINE AND WHEN THEY DID THIS THE CUSTOMER STATED THAT THEY COULD HEAR SOME TYPE OF PRESSURIZING AIR SOUND COMING FROM THE RIGHT SIDE OF THE INSTRUMENT. THE CUSTOMER DID NOT FEEL COMFORTABLE PRECEDING ANY FURTHER WITH TROUBLESHOOTING SO I WILL DISPATCH. WECART PRESSURE LOW 35PSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448528 ↗
• MalfunctionFeb 15, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II FLOW CYTOMETER THAT THERE WAS A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE ASPIRATOR ARM DRIPS EVERY TIME THEY PERFORM A SIT FLUSH. FOR THE REST, THE INSTRUMENT IS READING SAMPLE CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381338 ↗
• MalfunctionNov 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II FLOW CYTOMETER THAT WHEN MEASURING THE STEM CELL KITS, THE ABSOLUTE VALUES OF THE CELLS ARE NOT CORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN MEASURING THE STEM CELL KITS, THE ABSOLUTE VALUES OF THE CELLS ARE NOT CORRECT. IT SEEMS THAT TOO FEW TRUECOUNT BEADS ARE BEING MEASURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839335 ↗
• MalfunctionNov 15, 2022Break

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II FLOW CYTOMETER THAT THERE WAS A BROKEN FLUIDICS CART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COUPLING BROKEN FLUIDICSCART LEFT SIDE SHEATH TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801185 ↗
• MalfunctionOct 10, 2022Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II FLOW CYTOMETER THAT THERE IS LIQUID LEAKING FROM CART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. LIQUID LEAKING FROM CART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569850 ↗
• MalfunctionSep 19, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II FLOW CYTOMETER THAT THERE IS A BAD WAIST LEVEL SENSOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THAT AT THE TIME OF INSPECTION, THERE WAS A LEAK FROM THE BASE OF THE WAIST LEVEL SENSOR TUBE, SO I REPLACED IT. FSE REPLACED THE WASTE LEVEL SENSOR, AND AFTER THAT, THE ISSUE WAS RESOLVED. IT WAS CONFIRMED THAT THE INSTRUMENT WORKED NORMALLY. WAS THE LEAK FLUID OR AIR? FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451489 ↗