FACS 337146Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00382903371464), received between Jun 23, 2020 and Aug 28, 2025 — classified as 102 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, 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 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJul 9, 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 ISSUE. CELLS FROM ONE TUBE ARE TRANSFERRED TO THE NEXT TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706620 ↗
• MalfunctionJul 9, 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 CARRY OVER OF PATIENT SAMPLES OCCURRED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706371 ↗
• MalfunctionMay 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD LYSE WASH ASSISTANT EXPERIENCES CARRYOVER ISSUES. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "WE GENERALLY OBSERVE THAT CELLS ARE OCCASIONALLY CARRIED OVER INTO THE LWAS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375799 ↗
• 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 FACS¿ LYSE WASH ASSISTANT. 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 EMAIL: WE NOTICED TODAY THAT THE SAMPLES THAT RAN LOOKED A LITTLE WEIRD, SO WE RESET THEM AND USED THE OTHER WASHER AND THEY THEN LOOKED NORMAL. BOTH WASHERS GOT PM YESTERDAY AND I THINK SOMETHING HAPPENED DURING THAT. WE DID RUN QC ON IT THIS MORNING AND IT LOOKED OK BUT THE PATIENT SAMPLES LOOKED STRANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624358 ↗
• MalfunctionNov 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT ERRONEOUS RESULTS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM IS CD45 EVENTS THAT ARE SEEN AFTER PREPARATION IN LWA BUT NOT DURING MANUAL PREP. WE HAVE DEBUGGED WITH VARIOUS SAMPLE MATERIALS, FOR PERIPHERAL BLOOD THE PROBLEM IS NOT SO VISIBLE, ON THE OTHER HAND FOR BONE MARROW AND E.G. BRONCHOALVEOLAR LAVAGE" 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): NOT APPLICABLE. 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. 5.PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6): FURTHER DETAILS ON PATIENT IMPACT HAVE BEEN REQUESTED TO CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223557 ↗
• MalfunctionOct 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT THERE WERE ERRONEOUS RESULTS ACQUIRED. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: SAMPLES DO NOT LYSE PROPERLY AND REMAIN RED. THE PROBLEM OCCURS IN ALL SAMPLES IN A RACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996684 ↗
• MalfunctionOct 3, 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 FACS¿ LYSE WASH ASSISTANT. 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 RE-DRAWN, 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. WE ANALYZED TWO OF THE THREE ¿PIRS¿- LWAS: (B)(6) [PR (B)(4)], SN (B)(6) [(B)(4)]. ALSO LWA WITH SN (B)(6) [PR (B)(4)] WAS ANALYZED AS A REFERENCE FOR CARRYOVER. IT WAS NOT POSSIBLE TO CHECK ALSO LWA (B)(6), IT SHOULD BE TESTED. ALL THREE LWAS WERE CHECKED FOR CARRY OVER AND ALSO FOR CELL LOSS, USING STAINED WHOLE BLOOD. CARRYOVER OFF ALL CHECKED SYSTEMS WAS LOWER THAN 50 PPM, MEET SPECIFICATION. SELECTIVE CELL LOSS COULD NOT BE DETECTED WITH LYSED WHOLE BLOOD IN ALL THREE SYSTEMS. SELECTIVE LOSS OF MONOCYTES/LYMPHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861700 ↗
• MalfunctionSep 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2023-09-08: ADDITIONAL INFORMATION BASED ON FSE¿S EMAIL: WE ANALYZED TWO OF THE THREE ¿PIRS¿- LWAS: (B)(6), (B)(4), SN (B)(6), (B)(4). ALSO LWA WITH SN (B)(6), (B)(4) WAS ANALYZED AS A REFERENCE FOR CARRYOVER. IT WAS NOT POSSIBLE TO CHECK ALSO LWA (B)(6), IT SHOULD BE TESTED. ALL THREE LWAS WERE CHECKED FOR CARRY OVER AND ALSO FOR CELL LOSS, USING STAINED WHOLE BLOOD. CARRYOVER OFF ALL CHECKED SYSTEMS WAS LOWER THAN 50 PPM, MEET SPECIFICATION. SELECTIVE CELL LOSS COULD NOT BE DETECTED WITH LYSED WHOLE BLOOD IN ALL THREE SYSTEMS. A KAPPA-APC POSITIVE POPULATION WAS FOUND IN A SAMPLE TUBE DURING ACQUISITION, BUT SAMPLE HAS NOT SUCH POPULATION (SEEN IN REPEATED PREPARATION) PIR3011629.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761931 ↗
• MalfunctionSep 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WAS THERE ANY CARRYOVER OF PATIENT SAMPLES? YES, THIS WAS REPORTED BY THE CUSTOMER AND THE REASON FOR THE PIRS, BUT FOR THE MOMENT IT IS UNCLEAR IF IT IS RELATED TO LWA, BD FACSLYRIC OR PREPARATION / INTERNAL REAGENT CONTAMINATION. 2. WAS THERE ANY CONTAMINATION OF PATIENT SAMPLES? NO IF THIS IS A DIFFERENT QUESTION TO QUESTION 3 (IF CONTAMINATION DOESN´T MEAN DETECTED CARRIED OVER CELLS). 3. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? CAN BE ANSWERED WITH ¿NO¿ BECAUSE THEY NOTICED IT DURING THEIR STANDARD PLAUSIBILITY CHECKS. 4. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 5. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 6. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. 7. WHAT IS THE CURRENT MEDICAL STATUS? N.A.THE SAMPLE IS NOT SEPARATED, THE BLOOD IS DARK RED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745959 ↗
• MalfunctionSep 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ANALYZED TWO OF THE THREE ¿PIRS¿- LWAS: (B)(6), SN (B)(6). ALSO LWA WITH SN (B)(6) WAS ANALYZED AS A REFERENCE FOR CARRYOVER. IT WAS NOT POSSIBLE TO CHECK ALSO LWA (B)(6), IT SHOULD BE TESTED. ALL THREE LWAS WERE CHECKED FOR CARRY OVER AND ALSO FOR CELL LOSS, USING STAINED WHOLE BLOOD. CARRYOVER OFF ALL CHECKED SYSTEMS WAS LOWER THAN 50 PPM, MEET SPECIFICATION. SELECTIVE CELL LOSS COULD NOT BE DETECTED WITH LYSED WHOLE BLOOD IN ALL THREE SYSTEMS CARRYOVER OF CELLULAR MATERIAL FROM ONE SECONDARY TUBE INTO ANOTHER DURING LQC PROGRAM DUO LYSE WITH WASH CD19 BV510 LOW/CD BV421 HIGH POPULATION, PIR3011630.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741813 ↗
• MalfunctionAug 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; 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. THE FOLLOWING INFORMATION WAS PROVIDE BY THE INITIAL REPORTER: CARRY-OVER SOMETIMES OCCURS AFTER MEASURING LARGE PATHOLOGICAL POPULATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499747 ↗
• MalfunctionAug 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PREPARER DOES NOT LYSE THE SAMPLES CORRECTLY AND THE VOLUME IS NOT CORRECT. MDR SAFETY CHECKLIST -- PATIENT SAMPLES (CASE): 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? UNKNOWN. 3.IF THE 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. 5.PROVIDE DETAILS ¿ HOW AND TO WHAT EXTENT? IT WAS NOT NEEDED TO REDRAW THE PATIENTS BECAUSE THERE WAS ENOUGH SAMPLE TO REPEAT MANUALLY THE PREPARATION. THERE WAS A DELAY IN THE DIAGNOSIS BUT AT THE MOMENT SHE DOESN¿T KNOW IF THERE WILL BE A DELAY IN THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477855 ↗
• MalfunctionJul 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ LYSE WASH ASSISTANT THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THIS ISSUE? YES. WERE SAMPLES CONTAMINATED? YES. THE CUSTOMER REPORTED THAT WHEN A CARROUSEL WITH SAMPLE IS PLACED ON THE DEVICE IT COMES OUT WITH BLOOD SPLATTERS ON TOP. THE CUSTOMERS SEES THAT DURING THE SUCKING UP OF THE LYSE A DROP COMES BACK DOWN FROM THE NEEDLE ON TOP OF THE CARROUSEL. CONTAMINATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303665 ↗
• MalfunctionJul 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ LYSE WASH ASSISTANT THAT THERE WAS CARRYOVER INVOLVING PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE THERE ANY ERRONEOUS RESULTS ON PATIENT SAMPLES? NO WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? YES WITH THE POWER ON, THE PROBE MOVES BY HAND, SO NO PRESSURE IS APPLIED. CELL WASH MOTION FAULT ALSO OCCURS WHEN WASH ONLY IS EXECUTED. LYRIC'S SAMPLE PRETREATMENT DEVICE (LWA) GOT AN ERROR WITH "DISPENSE PROBE MOTION FAULT" AND STOPPED WORKING. MR. KITANI FROM BD CAME TO US FOR REGULAR MAINTENANCE TWO DAYS AGO, SO PLEASE CONTACT US AS SOON AS POSSIBLE. THE ERROR "DISPENSE PROBE MOTION FAULT" IS DISPLAYED AND DOES NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276259 ↗