BD FACSCalibur 342973Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382903429738), received between Aug 10, 2020 and Mar 31, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHOWING WRONG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655373 ↗
• MalfunctionApr 18, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR FLOW CYTOMETER CARRYOVER BETWEEN PATIENT SAMPLES HAD OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS A SIP DRIP. CUSTOMER PROBLEM: SIP DRIP. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: ONGOING ISSUE. NEXT STEPS (IF NECESSARY): REFERRING CASE TO FIELD SERVICE. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? YES. SOFTWARE VERSION? UNKNOWN. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? YES. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? NO. WHAT WAS THE FLUID THAT LEAKED/SPILLED? SHEATH. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) SIP. 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. CALLER REPORTS THAT THEY CANNOT RUN AS THERE IS CARRYOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138616 ↗
• MalfunctionMar 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE RUNNING THE BD FACSCALIBUR FLOW CYTOMETER BIOHAZARDOUS WASTE LEAKED OUTSIDE OF THE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE ADAPTER THAT ATTACHES THE SHEATH FILTER HAS CRACKED. 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 13663598 ↗
• MalfunctionNov 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCALIBUR 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? 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? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. ABNORMAL RESULTS"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863790 ↗
• MalfunctionJun 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR FLOW CYTOMETER WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CLEANING FLUID LEAKS OUT FROM UNDER THE MACHINE INSTEAD OF GOING DOWN INTO THE SLUDGE TANK. IS THE LEAK FLUID OR AIR? FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? INSIDE AND DRIPPING OUT OF INSTRUMENT WAS THE FLUID SPRAYING UNDER PRESSURE? NO. IS LEAKED LIQUID TYPE KNOWN? BIOHAZARDOUS OR NON-BIOHAZARDOUS? NO FACS FLOW AND WASTE. DID THE LEAKED LIQUID HAVE BLEACH MIXED IN? NOT WHEN I WAS THERE. WAS ANYONE INJURED DUE TO THE LEAKED LIQUID? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11969343 ↗
• MalfunctionMay 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD FACSCALIBUR FLOW CYTOMETER ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: FACSCALIBUR-ABNORMAL RESULTS, NOT USED FOR PATIENT TREATMENT 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. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838270 ↗
• MalfunctionNov 5, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED WHILE USING A BD FACSCALIBUR FLOW CYTOMETER, AS INDICATED BY "A LARGE GAP BETWEEN SAME SPECIMEN SAMPLES." THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSCALIBUR'S EXPERIMENTAL RESULTS IN THE MORNING AND THE EXPERIMENTAL RESULTS IN THE AFTERNOON HAVE A LARGE GAP, AND THERE IS A LARGE GAP BETWEEN THE SAME SPECIMENS AND NOT USED FOR PATIENT TREATMENT. CLINICAL USE, APPLY FOR TELEPHONE GUIDANCE. CLINICAL USE. CUSTOMER CONDUCTED A REPEAT/DIFFERENT TEST TO CONFIRM THE RESULTS, THE PROBLEM REMAINS. THERE WAS NO IMPACT TO PATIENT SAMPLES AND NO PHYSICAL HARM/INJURY DUE TO THE ISSUE. NO INCORRECT RESULTS BEEN USED. NO DELAY OR ALTERCATION OF TREATMENT DUE TO THIS PROBLEM.

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

  MAUDE report 10795908 ↗
• MalfunctionNov 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH A BD FACSCALIBUR FLOW CYTOMETER THE PATIENT SAMPLE RESULTS FOR WBC WERE TOO HIGH. SAMPLE RECOLLECTED AND RERAN AND THE RESULTS WERE WITHIN SPECIFICATION. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE VALUES OF THE LEUCOCOUNT RBC KIT (LOT LC0920) FOR WBC HIGH FAILED BECAUSE VALUES WERE OUT RANGE (TOO HIGH). INSTRUMENT PASSED FACSCOMP WITHOUT ISSUES. SAMPLES WERE PREPARED MANUALLY. CUSTOMER TOOK AFTERWARDS A FRESH VIAL AND VALUES WERE WITHIN SPECS. THE SAMPLE ANALYZED WERE PATIENT SAMPLE. IT IS NOT CLEAR WHETHER THE RESULT WAS CORRECT OR NOT. THE SAME SAMPLES PRODUCED 2 DIFFERENT RESULTS THAT CANNOT BE EXPLAINED BY THE APPLICATION SPECIALIST. NO INCORRECT TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE RESULT. NO HARM WAS DONE TO THE PATIENT AND ALSO NO DELAY IN THE TREATMENT.

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

  MAUDE report 10785454 ↗
• MalfunctionOct 6, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE WITH A BD FACSCALIBUR FLOW CYTOMETER THERE WAS AN ERROR MESSAGE DURING RUN WITH PATIENT SAMPLES, HOWEVER, THE SAMPLES WERE ABLE TO BE FULLY PROCESSED. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMMUNICATION WAS MADE WITH THE USER AND SUGGESTIONS WERE MADE TO LAUNCH THE PROGRAM AGAIN. THE ËRROR PROGRAM¨ MESSAGE APPEARED AT THE END OF RUNNING THE SAMPLES, BUT THE SAMPLE WAS PROCESSED.¿ ADDITIONALLY, ON 2020-9/15 2020 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THERE ANY IMPACT TO THE PATIENT(S)? NO. WERE SAMPLES REDRAWN? NO. WAS THERE ANY DELAY IN TREATMENT? NO. THE RUN WAS WITH PATIENT SAMPLES. THE EQUIPMENT IS USED FOR CLINICAL TESTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10639522 ↗
• MalfunctionAug 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT WITH A BD FACSCALIBUR FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: EQUIPMENT WITH AN OPEN ARM DRIPS THROUGH THE NEEDLE. ADDITIONALLY, ON 2020-7-21 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? WASTE . 5. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO¿. ADDITIONALLY, ON 2020-7-29 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE IF WASTE LINE, WHETHER IT IS MIXED WITH BLEACH OR DECONTAMINATE? ONLY WASTE, NO MIX..

  Patient problems: No Patient Involvement

  MAUDE report 10385855 ↗