FACSCanto 339473Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903394739), received between Jun 16, 2020 and Dec 14, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES ON BD FACSCANTO¿ ERRONEOUSE RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THERE IS A PROBLEM WITH THE MULTITEST 6 COLOR TBNK REAGENT. THE ABSOLUTE COUNTS OF ALL MARKERS ARE NOT AS EXPECTED AND DIFFER GREATLY FROM THE COUNTS MADE WITH ANOTHER METHOD (BLOOD CELL COUNT) BOTH IN THE MULTICHECK CONTROL AND IN THE ANALYZED SAMPLES. 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, THE ERRONEOUS RESULTS HAVE NOT BEEN USED TO DECIDE THE TREATMENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002823 ↗
• MalfunctionNov 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLE ON BD FACSCANTO¿ AN ERRONEOUS RESULT WAS OBTAINED. RESULTS WERE NOT REPORTED AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CUSTOMER REPORTS THAT THE INSTRUMENT THIS MORNING ASPIRATED THE FIRST TUBE OF THE ACQUISITION COMPLETELY WITHIN SECONDS. ALSO 2 WEEKS AGO, WHILE READING A PATIENT SAMPLE WITH FACSCANTO CLINICAL 2.4 THE SIGNAL ON SSC DECREASED TAKING THE TRUCOUNT BEADS OUT OF THE GATE. THE SAME SAMPLE REREAD ON A SECOND INSTRUMENT (FACSCANTO II) SHOWED NO PROBLEMS. THE SAMPLE WAS THEN REREAD ON THE INSTRUMENT IN QUESTION AND THE PROBLEM DISAPPEARED. AN ERRONEOUS RESULT WAS PRODUCED BUT WAS IMMEDIATELY IDENTIFIED BY THE OPERATOR AND WHICH WAS NOT USED FOR DIAGNOSTIC PURPOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787910 ↗
• MalfunctionJun 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING PATIENT SAMPLES WITH BD FACSCANTO¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: FACSCANTO II-INCORRECT RESULT. PATIENT SAMPLES ARE USED, AND THERE IS NO IMPACT ON PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11969357 ↗
• MalfunctionJun 9, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED WHILE TESTING PATIENT SAMPLES ON BD FACSCANTO¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: INCORRECT RESULT. PATIENT SAMPLES ARE USED, AND THERE IS NO IMPACT ON PATIENT RESULTS. 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. 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6). 6. WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966712 ↗
• MalfunctionFeb 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE TESTING WITH BD FACSCANTO" FACSFLOW SALINE SOLUTION UNDER PRESSURE SPRAYED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WET CART FLUIDICS CHECK VALVE HAS RUPTURED AND NEEDS TO BE REPLACED. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WHAT WAS THE FLUID THAT LEAKED? FACSFLOW SALINE SOLUTION. WAS THE SPRAY OF FLUID UNDER PRESSURE? YES, .FACSFLOW SALINE SOLUTION. WAS THE CUSTOMER EXPOSED TO BIOHAZARD FLUIDS (EXAMPLE: BLOOD, TISSUE, WASTE)? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11258472 ↗
• MalfunctionJan 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO (B)(6). AFTER THE SIT FLUSH, THE LIQUID IS NOT ASPIRATED BY THE ARM. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION. YES. WHAT WAS THE FLUID THAT LEAKED. FACSFLOW IF SO WAS THERE LEAKED FLUID IN UNDER PRESSURE. NO. WHAT IS THE SOURCE OF LEAK WASTE LINE OR NON-WASTE LINE. WASTE. IF WASTE LINE, WHETHER IT IS MIXED WITH BLEACH OR CONTAMINATION. NO. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS. NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK, NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11120484 ↗
• MalfunctionJun 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OF WASTE OCCURRED OUTSIDE OF INSTRUMENT WITH A BD FACSCANTO¿ II CYTOMETER IVD 5/3 SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USER REPORTED FLUID LEAKAGE FROM THE CYTOMETER. ADDITIONALLY, ON 2020-05-29 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? YES. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN WHAT IS THE SOURCE OF LEAK A WASTE LINE OR NON-WASTE LINE? UNKNOWN . WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? YES. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO . WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? YES . WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. ADDITIONALLY, ON 2020-06-09 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS LEAKAGE FROM INSTRUMENT. WE DO NOT KNOW WHAT IT WAS, FACSCLEAN OR FROM WASTE LINE. THE CUSTOMER DID NOT HAVE ANY PHYSICAL CONTACT (LIKE CLOTHING, SKIN ETC.). CUSTOMER USED MEDICAL GLOVES TO CLEAN THE PUDDLE. THERE WAS NOT ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK.

  Patient problems: No Patient Involvement

  MAUDE report 10158622 ↗