FACSCanto 338962Recalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 00382903389629), received between May 7, 2020 and Aug 1, 2025 — classified as 167 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (81 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 167 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USING BD FACSCANTO¿ II ERRONEOUS RESULTS WERE ACQUIRED. THERE WAS NO PATIENT IMPACT NOR ADVERSE EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CYTOMETER IS GIVING RARE POPULATIONS AND REQUIRES LACK OF SCALING AREA ADJUSTMENT. "1. WERE THERE ERRONEOUS RESULTS IN PATIENT SAMPLES FOR DIAGNOSTIC TESTING? YES, THE POPULATION WAS IDENTIFIED, BUT THE RESULT WAS NOT RELEASED TO THE PATIENT. 2. WAS THERE ANY DELAY IN TREATMENT DUE TO THE PROBLEM? THE SAMPLE WAS ORDERED TO BE SUBROGATED. 3. IF PATIENTS WERE RE-SAMPLED, WERE THERE ANY CHANGES OR DELAYS IN TREATMENT? THE SAMPLES WERE SUBROGATED AND THE APPROPRIATE RESULT WAS RELEASED, THERE WAS NO WRONG TREATMENT 4. WAS THERE ANY PHYSICAL HARM OR INJURY TO THE PATIENT DUE TO THE PROBLEM? NO"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602853 ↗
• MalfunctionDec 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II FLOW CYTOMETER FSC & SSC SIGNAL SHIFT TOWARD THE ORIGIN. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE IS PHANTOM AIR COLLECTING IN THE FLOW CELL DURING SAMPLE ACQUISITION CAUSING THE SCATTER PLOT TO SHIFT TOWARD THE ORIGIN AXIS. 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): 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 OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321726 ↗
• MalfunctionNov 1, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II THEY SAW ERROR MESSAGES THEY WERE ABLE TO BYPASS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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 ) ERROR E089. THEY HAVE FLUIDICS BOARD REQUESTED SHUTDOWN MESSAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18050588 ↗
• MalfunctionOct 27, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART ERROR MESSAGE OCCURRED, CUSTOMER BYPASSED AND CONTINUE TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WHEN RUN CAROUSEL IT FAILS TO PRESSURIZE 1ST FEW SAMPLES, ERROR MESSAGE (#COULD NOT PRESSURIZE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017514 ↗
• MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART TUBE COULD NOT PRESSURIZE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED ERROR TUBE COULD NOT PRESSURIZE. CHECK WET CART PRESSURE IS OK AT 65, ERROR OCCUR WHILE USING LOADER. LIFTER ROD IS CLEAN, CUSTOMER CHECK DRAWER IS PROPERLY LOCKED INTO POSITION. THERE WERE NO BROKEN WIRES IN THE CABLE BEAM FROM THE LOADER. CUSTOMER ALSO TRIED REPLACE BAL SEAL, NO DAMAGE FOUND ON THE SIT AREA AROUND BAL SEAL/NUT RETAINER. ERROR STILL PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016548 ↗
• MalfunctionOct 20, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART ERROR MESSAGE FOR WASTE WAS RECEIVED AND BYPASSED. THERE WAS NO REPORT OF ANY PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT WASTE IS SHOWING AS FULL EVEN THOUGH IT IS EMPTY 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17971962 ↗
• MalfunctionOct 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THAT ERROR MESSAGES WERE BYPASSED AND TESTING WAS ABLE TO CONTINUE DURING USE WITH THE BD FACSCANTO¿ II. CUSTOMER USED A DIFFERENT MODE (SINGLE TUBE MODE) OF TESTING SAMPLES. 16OCT2023 RECEIVED EMAIL (ATTACHED) FROM CTS: HELLO, THE CANTO/CANTO10/CANTO II HAS THE ABILITY TO RUN WITH THE CAROUSEL/LOADER OR IN SINGLE TUBE MODE. IN THIS INSTANCE, THE CUSTOMER BYPASSED THIS PARTICULAR ERROR MESSAGE FOR THE CAROUSEL/LOADER AND RAN IN SINGLE TUBE MODE. I HOPE THIS HELP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - ERROR MESSAGES (CASE) 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 TUBE GUIDE NOT IN PLACE ERROR. TUBE GUIDE NOT IN PLACE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906537 ↗
• MalfunctionOct 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  COULD YOU PLEASE VERIFY - ERROR MESSAGE WAS OBSERVED BY THE USER DURING LONG CLEAN OF THE INSTRUMENT. DID THE CUSTOMER BYPASSED THE ERROR MESSAGE AND TESTED PATIENT SAMPLE? "YES, ERROR DURING LONG CLEAN. BUT OTHERWISE THE INSTRUMENT WAS STILL USED FOR SAMPLES AS NORMAL. LONG CLEAN DID NOT PREVENT OTHER NORMAL OPERATION OF THE INSTRUMENT." USER WAS NOT TESTING PATIENT SAMPLE DURING LONG CLEAN PROCESS. IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING CONTINUED DURING USE WITH THE BD FACSCANTO¿ II. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - ERROR MESSAGES (CASE) 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 FLUIDIC BOARD REQUESTING SHUTDOWN - FLOAT SWITCH TIMEOUT DURING A LONG CLEAN. FLUIDIC BOARD REQUESTING SHUTDOWN - FLOAT SWITCH TIMEOUT DURING A LONG CLEAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906536 ↗
• MalfunctionOct 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO?II FLOW CYTOMETER ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAD IRREGULARITIES WITH SAMPLE RESULTS. CUSTOMER STATES CST DID HOWEVER PASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877180 ↗
• MalfunctionSep 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSCANTO¿ II. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES 2. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796011 ↗
• MalfunctionSep 1, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE WITH THE BD FACSCANTO¿ II ERROR MESSAGES WERE BYPASSED AND USER COULD PROCEED WITH TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERROR MESSAGE CHECKLIST: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? UNKNOWN. 2. WAS THERE AN ERROR MESSAGE? YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? YES. 4. IS THIS PRESTO? NO. I CALLED THE CUSTOMER BACK AND HAD HIM LOG IN AS SERVICE. WE LOOKED AT THE LASER TAB AND THE BLUE LASER CURRENT. THE CURRENT MEASURED WAS 1.84 AND THE REFERENCE WAS 1.54. I HAD HIM CHANGE THE REFERENCE VALUE TO 1.84. HE LOGGED OUT AND SAVED THE THE VALUE. RAN A TUBE OF WATER JUST TO SEE IF THE ERROR POPPED UP AND IT DID NOT. I HAD THE CUSTOMER LOOK AT THE LAST KNOWN GOOD PERFORMANCE CHECK FOR THE CURRENT RANGE. WITH FSC TRIGGER THE CURRENT RANGE IS 1.23 TO 1.85. I INFORMED THE CUSTOMER THEY WERE AT THE HIGH END OF THE RANGE. I INFORMED HIM THAT IF THE ERROR OCCURS AGAIN, MOST LIKELY THERE WILL BE AN ISSUE WITH THE LASER. CUSTOMER IS ACCEPTING. SYSTEM IS WORKING PROPERLY. CUSTOMER IS SATISFIED. CASE IS COMPLETE. THE ERROR HAS BEEN OCCURRING OVER THE LAST 2 WEEKS MORE FREQUENTLY. I WAS ASKING THE CUSTOM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671406 ↗
• MalfunctionAug 15, 2023Incorrect, 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: 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. 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): UNKNOWN. CUSTOMER HAS TRIED TWO DIFFERENT LOTS OF TRUCOUNT AND THE PROBLEM OCCURS WITH BOTH. IT DOES NOT HAVE 7 COLOR SETUPS TO CHECK THE TECHNICAL PERFORMANCE OF THE INSTRUMENT WITH THE CANTO CLINICAL. I ASK YOU TO RUN AT LEAST THE CST, WHICH DO NOT HIGHLIGHT ANY PROBLEMS . I PASS THE CASE TO SATA. IN THE TBNK ESSAY THE TRUCOUNT MARBLES DO NOT LAND IN THE GATE THEY SHOULD LAND IN AND ARE VERY SCATTERED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553699 ↗
• MalfunctionJun 21, 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 CARRYOVER INVOLVING PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? NO HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS CST FAILS WITH CANNOT PLACE BEADS ON SCALE WITH MAXIMUM PMTV, THRESHOLD SET TO FITC - SEEN ON HISTOGRAM POPULATION, ON APC - SEEN ON HISTOGRAM POPULATION, ASKED TO RESTART THE CUSTOMER REPORTED THAT POPULATION ON FSC/SSC IS PUSHED AGAINST AXIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172050 ↗
• 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 THAT THERE WAS ERRONEOUS RESULTS.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:UNUSUAL POPULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714492 ↗
• MalfunctionApr 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 THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFORMATION RECEIVED FROM TASK (B)(4) - (WFI-SAFETY ALIGNMENT), PLEASE FIND BELOW INFORMATION. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? THEY WERE PATIENTS SAMPLES BUT NO ERRONEOUS RESULTS HAVE BEEN OBTAINED. 2. WAS THERE ANY DELAY IN TREATMENT DUE TO THE ISSUE? NO, THERE WASN¿T. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY IN TREATMENT? NO, THEY WERE NOT REDRAWN. THE CUSTOMER HAD A SECOND SAMPLE FROM THE SAME PATIENTS AND SHE IS WAITING FOR THE ISSUE TO BE FIXED TO REPEAT THE TEST. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO, THERE WASN¿T . I RAN 6 DIFFERENT TUBES, IN THE SAME EXPERIMENT, ALL UNDER THE SAME CONDITIONS. THESE ARE SAMPLES WITH FLUORESCENT MAGNETIC BEADS FOR 12 CYTOKINES, THE BEADS ARE PLOTTED AGAINST FITC AND PE. UNFORTUNATELY, THE FIRST THREE TUBES (CYT23028-30) GAVE ME A READING WITH VERY GRAINY CLOUDS (IN THE FITC PLOT ON PE); THE LAST THREE TUBES, ON THE OTHER HAND, (CYT23031-33) GAVE ME THE EXPECTED CLOUDS. I HAVE TO COMPARE THESE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678789 ↗
• MalfunctionApr 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 THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): NO. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO. 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. AN UNMARKED SAMPLE SHOWS POSITIVE SIGNALS IN ALL FLUORESCENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678745 ↗
• MalfunctionMar 27, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS THE ASSAY DESCRIBED IN THE CASE DESCRIPTION PRODUCED AN INCORRECT MEASUREMENT OF THE CONTROL SAMPLES WHICH ARE USED TO SET A 'BASELINE' FOR THE PATIENT'S SAMPLE. THE ERRONEOUS RESULT WAS NOT USED BECAUSE A SECOND INSTRUMENT DISPROVED THE RESULT. CUSTOMER WAS RUNNING A TEST FOR HEREDITARY SPHEROCYTOSIS. CUSTOMER ANALYZES EMA BINDING TO ERYTHROCYTES IN A PATIENT'S SAMPLE AND SIX BLOOD SAMPLES FROM HEALTHY DONORS AS CONTROLS. IN THIS ANALYSIS THEY COMPARE THE MFI VALUE FOR EMA SIGNAL IN FITC CHANNEL TO THE MEDIAN OF THE NORMAL BLOOD MFI VALUES TO GET AN ESTIMATION OF THE EMA EXPRESSION IN RELATION TO NORMAL SAMPLES. THE PROBLEM WITH THE SAMPLE ANALYSIS WAS THAT WHEN THEY LOOKED AT THE MFI VALUES IT APPEARED THAT THEY INCREASED FORM ONE CONTROL TUBE TO THE OTHER; ALSO THE MFI VALUES WERE GENERALLY LOWER THEN THEY EXPECT THEM TO BE. WHEN THEY RAN THE SAME SAMPLES ON THEIR OTHER CANTO, THE MFI VALUES WERE GENERALLY HIGHER, AND NO PATTERN OF RISING MFI VAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16623615 ↗
• MalfunctionMar 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SAMPLES ARE ALL POSITIVE. 1. ARE THERE ANY ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2. WAS THERE ANY DELAY IN TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? ( IF NO, NO FURTHER QUESTIONS REQUIRED) NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607605 ↗
• MalfunctionMar 22, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ II THAT THERE WAS AN ERROR MESSAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. WAS THERE AN ERROR MESSAGE? YES. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? YES. IS THIS A PRESTO? NO. CUSTOMER PROBLEM: ERROR MESSAGES THAT THE BLUE, RED, AND VIOLET LASERS ARE OVER HEATING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: ERROR MESSAGES THAT THE BLUE, RED, AND VIOLET LASERS ARE OVER HEATING. ISSUE HAPPENS WITHIN THE FIRST HOUR THAT THE INSTRUMENT IS TURNED ON. CUSTOMER CLICKS THROUGH THE ERROR MESSAGE. CUSTOMER IS REQUESTING THAT THE FSE COME IN TO CHECK INSTRUMENT. ERROR MESSAGES THAT THE BLUE, RED, AND VIOLET LASERS ARE OVER HEATING. ISSUE HAPPENS WITHIN THE FIRST HOUR THAT THE INSTRUMENT IS TURNED ON. CUSTOMER CLICKS THROUGH THE ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595472 ↗