FACSRecalls & reported problems across all models

We found 5 models of FACS by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 230 adverse event reports in the FDA's MAUDE database, received between May 19, 2020 and Feb 6, 2026 — classified as 3 injuries, 227 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (115 reports).

2 FDA recall records name at least one of these models by its device identifier, 1 still open.

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

FACS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 3, 2025Open, Classified

   Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

   Z-2078-2025 · Root cause: Process control · Recall details · FDA record ↗

2. May 16, 2018Terminated

   The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

   Z-2598-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported FACS problems

FACS models

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

• FACS 647205

  Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis
  123 reports
• FACS 337146

  STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
  102 reports
• FACS 335775

  Counter, differential cell
  1 recall4 reports
• FACS 662879

  Flow cytometric reagents and accessories.
  1 recall0 reports
• FACS 349202

  PRODUCTS, RED-CELL LYSING PRODUCTS
  1 report

Recent FACS adverse event reports

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

• MalfunctionFeb 6, 2026Contamination

  IT WAS REPORTED THAT DURING USE OF BD FACS¿ SAMPLE PREP ASSISTANT III, FOREIGN MATTER/CONTAMINATION IN INSTRUMENT THAT IMPACTED PATIENT RESULTS WAS OBSERVED. CONTAMINANT IS IN A POSITION WHERE IT IMPACTED A READOUT TO BE USED CLINICALLY. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT SAMPLES NOT BEING PROCESSED CORRECT. CUSTOMER REPLACED SYRINGE BUT ISSUE PERSISTS. PATIENT SAMPLES CHECKLIST: 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. YES. 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. NO. CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. PATIENT SAMPLES CONTAMINATED. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SAMPLES WERE NOT PROPERLY PROCESSED AND THERE WAS A R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277294 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE WASHING THE FILTER OF THE BD FACS¿ SAMPLE PREP ASSISTANT III, LIQUID SPLASHED INTO THE USER¿S EYES. THE USER WAS NOT WEARING THE APPROPRIATE PPE AS SPECIFIED IN THE IFU, AND THERE WAS NO PRODUCT FAILURE ASSOCIATED WITH THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORTED THAT THE PREVIOUS WEEK, DURING USER MAINTENANCE, WHEN THE FILTER OF THIS EQUIPMENT WAS OPENED, SHE WAS SPLASHED WITH LIQUID FROM THE EQUIPMENT'S WASTE PRODUCTS INTO HER EYES. THE USER REPORTED THIS AND FOLLOWED THE INSTITUTION'S PROCEDURES FOR THIS TYPE OF SITUATION, BUT IT WAS ONLY AFTER THE ENGINEER'S VISIT THAT THE INCIDENT WAS REPORTED TO BD. ADDITIONAL INFORMATION PROVIDED BY THE TECHNICAL SERVICES TEAM: THE INCIDENT OCCURRED WHEN THE USER WAS WASHING THE INSTRUMENT¿S FILTER, AFTER IT HAD BEEN REMOVED FROM THE EQUIPMENT. IT IS REPORTED THAT THE USER REMOVED THE FILTER WITHOUT ANY ISSUES, AND WHILE WASHING IT UNDER RUNNING WATER, LIQUID SPLASHED INTO THEIR EYES. THE USER WAS NOT WEARING SAFETY GLASSES. THERE ARE NO COMPLAINTS OF PROBLEMS RELATED TO THE INSTRUMENT OR BD DISPOSABLES. THERE WERE NO IMMEDIATE CONSEQUENCES FOR THE USER AT THE TI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794926 ↗
• MalfunctionAug 28, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING USE OF THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER INVOLVING PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915342 ↗
• MalfunctionJul 3, 2025Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CONTAMINATED LINES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM GETTING HIGH BACKGROUND ON ALL OF MY LEUKEMIA AND LYMPHOMA PANELS. I HAVE ISOLATED IT TO SOMETHING ON THE LWA. THE ISSUE ONLY HAPPENS WHEN I RUN ON THE LWA. IF I DO A MANUAL PROCEDURE EVERYTHING WORKS FINE. PATIENT SAMPLES CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22399346 ↗
• MalfunctionJun 13, 2025Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER WAS OBSERVED ON PATIENT SAMPLES. NO PATIENT IMPACT WAS IDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE SUSPECT CARRY OVER BETWEEN SAMPLES IN THE LWA. WE HAVE EXPERIENCED ¿UNEXPECTED¿ SICK CELLS IN TWO DIFFERENT SAMPLES ON TWO DIFFERENT DAYS. ONCE WE REPEAT THE SAMPLES, WE NO LONGER SEE THE ¿UNEXPECTED¿ CELLS. IN BOTH SAMPLES THE PREPARATION WAS PERFORMED ON THE LWA AND IN BOTH CASES OTHER SAMPLES WERE PROCESSED (WASHED AND LYSED) IN A ROW IN CAROUSEL IN THE LWA. IT WAS ALSO COMMON BETWEEN THE TWO SAMPLES WITH ¿UNEXPECTED¿ CELLS THAT THE SAMPLE JUST BEFORE IN THE ROW IN LWA CONTAINED HIGH NUMBER OF SICK CELLS. THE IMMUNOPROFILE OF THE SICK CELLS CORRESPOND TO THE ¿UNEXPECTED¿ CELLS. WE THEREFORE TESTED THE HYPOTHESIS OF CARRY OVER. WE DO SEE CARRY OVER OF SICK UNEXPECTED CELLS BETWEEN SAMPLES. IN THIS CASE WE HAD PLACED FOUR TUBES IN THE LWA: SICK ¿ HEALTHY ¿ SICK- HEALTHY. WE WASHED AND LYSED THE SAMPLES ACCORDING TO THE SCHEDULE BELOW: TEST 1: WE OBSERVED 26 SICK CELLS OUT OF A TOTAL OF 99.414 CELLS = CARRY OVER OF (B)(4). TEST 2: WE OBSERVE 39 SICK CELLS OUT OF TOTAL OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204571 ↗
• MalfunctionJun 13, 2025Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER WAS OBSERVED IN PATIENT SAMPLES. NO PATIENT IMPACT WAS IDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE SUSPECT CARRY OVER BETWEEN SAMPLES IN THE LWA. WE HAVE EXPERIENCED ¿UNEXPECTED¿ SICK CELLS IN TWO DIFFERENT SAMPLES ON TWO DIFFERENT DAYS. ONCE WE REPEAT THE SAMPLES WE NO LONGER SEE THE ¿UNEXPECTED¿ CELLS. IN BOTH SAMPLES THE PREPARATION WAS PERFORMED ON THE LWA AND IN BOTH CASES OTHER SAMPLES WERE PROCESSED (WASHED AND LYSED) IN A ROW IN CAROUSEL IN THE LWA.IT WAS ALSO COMMON BETWEEN THE TWO SAMPLES WITH ¿UNEXPECTED¿ CELLS THAT THE SAMPLE JUST BEFORE IN THE ROW IN LWA CONTAINED HIGH NUMBER OF SICK CELLS. THE IMMUNOPROFILE OF THE SICK CELLS CORRESPOND TO THE ¿UNEXPECTED¿ CELLS. WE THEREFORE TESTED THE HYPOTHESIS OF CARRY OVER. WE DO SEE CARRY OVER OF SICK UNEXPECTED CELLS BETWEEN SAMPLES. IN THIS CASE WE HAD PLACED FOUR TUBES IN THE LWA: SICK ¿ HEALTHY ¿ SICK- HEALTHY WE WASHED AND LYSED THE SAMPLES ACCORDING TO THE SCHEDULE BELOW: TEST 1: WE OBSERVED 26 SICK CELLS OUT OF A TOTAL OF 99.414 CELLS = CARRY OVER OF 0,03% TEST 2: WE OBSERVE 39 SICK CELLS OUT OF TOTAL OF 100.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204570 ↗
• MalfunctionMay 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III THE CUSTOMER REPORTED ERRONEOUS RESULTS THAT WERE REPORTED TO A CLINICIAN. 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 22045122 ↗
• MalfunctionMay 8, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT WHILE USING BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS CONTAMINATION WAS OBSERVED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FAILING LOT". "1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. YES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. PATIENT SAMPLES CHECKLIST: 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. YES. IF NO, NO FURTHER QUESTIONS REQUIRED. 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988548 ↗
• MalfunctionApr 22, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/ MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN- GO TO QUESTION #2.: CARRYOVER BETWEEN PATIENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881859 ↗
• MalfunctionApr 22, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING USE WITH BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CARRYING OUT IN-DEPTH TESTING OF THE INSTRUMENT'S PROPER FUNCTIONING CONTAMINATION - CARRY OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881388 ↗
• MalfunctionJan 10, 2025Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT. CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "IT WAS REPORTED BY THE CUSTOMER: SAMPLE CARRY-OVER"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123824 ↗
• MalfunctionDec 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH BD FACS LYSE WASH ASSISTANT CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2ND OF 2 REPORTS) THE CUSTOMER REQUESTED A CHECK OF THE CELL WASH PROBE RINSING SYSTEM AS HE FOUND CARRYOVER BETWEEN ONE SAMPLE AND ANOTHER. ADDITIONAL INFORMATION REPORTED BY CUSTOMER: THE CUSTOMER FOUND CARRYOVER BETWEEN 2 PATIENT SAMPLES AND REPROCESSED AND RETESTED BOTH SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854088 ↗
• MalfunctionDec 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH BD FACS LYSE WASH ASSISTANT CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 REPORTS) THE CUSTOMER REQUESTED A CHECK OF THE CELL WASH PROBE RINSING SYSTEM AS HE FOUND CARRYOVER BETWEEN ONE SAMPLE AND ANOTHER ADDITIONAL INFORMATION REPORTED BY CUSTOMER: THE CUSTOMER FOUND CARRYOVER BETWEEN 2 PATIENT SAMPLES AND REPROCESSED AND RETESTED BOTH SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832902 ↗
• MalfunctionJul 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OF PATIENT SAMPLE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WITH THIS LYSIS WASH WE SEE QUITE A LOT OF CARRY OVER. WE HAVE ALREADY CLEANED THE NEEDLE OURSELVES AND SOAKED IT IN WARM WATER, BUT THE CARRYOVER REMAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733845 ↗
• MalfunctionJul 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED BETWEEN PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED CONTAMINATION ISSUES: CELLS ARE TRANSFERRED FROM ONE TUBE TO THE NEXT. THIS COULD LEAD TO MISS INTERPRETATION OF THE RESULTS 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714174 ↗

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