BD FACSCaliburRecalls & reported problems across all models

We found 3 models of BD FACSCalibur by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Apr 26, 2019 and May 17, 2024 — classified as 74 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (42 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. 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

Most reported BD FACSCalibur problems

BD FACSCalibur models

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

• BD FACSCalibur 342975

  Counter, differential cell
  62 reports
• BD FACSCalibur 342973

  Counter, differential cell
  10 reports
• BD FACSCalibur 342976

  Counter, differential cell
  2 reports

Recent BD FACSCalibur adverse event reports

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

• MalfunctionMay 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR ERRONEOUS RESULTS OCCURRED AND REPORTED TO THE DOCTOR. NO PATIENT TREATMENT DELAY AND NO PATIENT INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THERE WAS SAMPLE FROM ONE PATIENT WHERE CD4+ WAS NOT DETECTED EVEN THOUGH IT WAS CONFIRMED BY OTHER LABORATORY THAT THESE ARE PRESENT. AT THE MOMENT IT IS NOT KNOWN WHERE THE FAULT LIES (SAMPLE PREPARATION, ANTIBODIES (BOUGHT FROM BD) OR ON THE INSTRUMENT ITSELF, THUS THE CASE IS BEING OPEN FOR INVESTIGATION PURPOSES. THE CD4 WAS NOT DETECTED IN THE BLOOD SAMPLE FROM ONE PATIENT (BUT WAS FOUND IN THE DIFFERENT LABORATORY IN FRANKFURT). THE CONTROLS WERE DETECTED SO CUSTOMER DOES NOT UNDERSTAND WHY IT HAPPENED AND TRIES TO GET TO THE BOTTOM OF THIS. THE DOCTOR WAS INFORMED - NO TREATMENT WAS AFFECTED BY THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346387 ↗
• MalfunctionJul 24, 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 RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CASE RELATED TO A EVENT RATE ISSUE; VALUES WERE NOT NORMAL AND WAS DUE TO A MISCONFIGURATION NO RESULTS INVOLVED, WERE ACTUALLY VALUES WITH BOTH SAMPLES, BUT WERE NOT RELEASED. COULD YOU CLARIFY WHAT THE "UNEXPECTED RESULTS" WOULD BE? VALUES WERE NOT NORMAL AND WAS DUE TO A MISCONFIGURATION WERE THE UNEXPECTED RESULTS WITH CONTROL SAMPLES OR WITH PATIENT SAMPLES? NO. RESULTS WERE ACTUALLY VALUES WITH BOTH SAMPLES, BUT WERE NOT RELEASED, SO THE PATIENT WAS NOT TREATED BASED ON THE RESULT AND WAS NOT SUBJECTED TO HARM. IF PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? NO. WAS THE PATIENT TREATED BASED ON THE OUTCOME? NO. WAS THERE ANY HARM TO THE PATIENT? NO. EQUIPMENT DID NOT ENABLE FL4 AT POWER UP, BEING NECESSARY TO ENABLE IT MANUALLY FOR CALIBRATION. HOWEVER, AFTER ACQUIRING THE SAMPLES THE RESULTS SHOWED UNEXPECTED RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379804 ↗
• MalfunctionMay 26, 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 RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT TODAY WHEN TURNING ON THE EQUIPMENT, THE CALIBRATION GAVE SOME ERRORS IN BOTH TUBE A AND TUBE B AND WHEN REPEATING THE PROCEDURE THEY WERE SUCCESSFUL, BUT THEY REREAD SAMPLES TAKEN THE DAY BEFORE AND THE RESULT WAS DIFFERENT. ACCORDING TO THEM, TO CARRY OUT A MORE RELIABLE COMPARISON, THEY REPEATED THE ACQUISITION WITH THE SAME SAMPLE SEVERAL TIMES AND THE RESULTS WERE DIFFERENT, OBTAINING A DIFFERENCE OF UP TO 50% IN THE COUNT OF THE CELLS IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009968 ↗
• 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 RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSCALIBUR-INACCURATE RESULTS. CLINICAL USE, USED PATIENT SPECIMENS BUT NOT APPLIED TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659786 ↗
• 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 ↗
• MalfunctionMar 14, 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 RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSCALIBUR - UNEXPECTED RESULT CLINICAL, NOT USED FOR PATIENT DIAGNOSIS, NO IMPACT ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538395 ↗
• MalfunctionMar 9, 2023Incorrect, 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 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 16513933 ↗
• MalfunctionJan 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 REULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIGH CELL ABSOLUTE COUNT IS REPORTED BY THE FSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273772 ↗
• MalfunctionJan 20, 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 WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSCALIBUR - ABNORMAL GRAPHICS, CLINICAL USE, RESULTS NOT USED FOR PATIENT DIAGNOSIS, OUT OF WARRANTY EQUIPMENT, QUOTE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215381 ↗
• MalfunctionJan 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR SAMPLE RESULTS IS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE RESULT NOT CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16190683 ↗
• MalfunctionNov 8, 2022Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ELECTRICAL SHOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT PRESENTS DISCHARGES ON THE SURFACE OF THE INSTRUMENT.

  Patient problems: Electric Shock

  MAUDE report 15754793 ↗
• MalfunctionOct 6, 2022Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THE LYMPHS COUNTS IS BELOW 2000. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORTS THAT THE LYMPHS COUNTS IS BELOW 2000.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554986 ↗
• MalfunctionSep 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR INSTRUMENT GIVING WRONG RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE THE SAMPLES ANALYZED ON THE INSTRUMENT PATIENT SAMPLES? YES. IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? YES. ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? NO. THE USER NOTICED THE ANOMALY BEFORE REPORTING, HENCE DIDN'T REPORT. WAS THERE ANY HARM TO THE PATIENT? NO, THE PATIENTS WERE ATTENDED TO BASED ON PREVIOUS RECORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451361 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT BD FACSCALIBUR¿ FLOW CYTOMETER HAD WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED (OUTSIDE INSTRUMENT). THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: FACSCALIBUR - UNABLE TO FLUSH SYRINGE OUTER TUBE CLINICAL USE." WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): NO. 4 WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): THE LIQUID WASTE 5 DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): BEFORE WASTE LINE 7 WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427905 ↗
• MalfunctionAug 11, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ON THE BD FACSCALIBUR¿ FLOW CYTOMETER IT WAS NOT POSSIBLE TO IDENTIFY WHY THE SOFTWARE DID NOT CORRECTLY PROCESS THE SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? PATIENT. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. WAS THE PATIENT TREATED BASED ON ERRONEOUS RESULTS? NO. SPECIFY IF ANY TESTING DONE WAS IVD OR RUO. IVD. WERE RESULTS REPORTED TO A PATIENT OR CLINICIAN AND ACTED ON? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210628 ↗

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