BD FACSLyric 662878Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00382906628787), received between Nov 4, 2020 and Aug 28, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Contamination” (9 reports).

2 FDA recall records name this device's 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, 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 18, 2026.

Recalls naming this device

1. Nov 1, 2024Class IIOpen, Classified

   On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

   Z-0748-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jan 2, 2019Class IIITerminated

   A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It is released for research use only.

   Z-0792-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Contamination; Contamination

  IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT INSTRUMENT HAS HIGH CARRYOVER. CONTAMINATION CHECKLIST: 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. CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. INSTRUMENT HAS HIGH CARRYOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915362 ↗
• MalfunctionAug 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION CHECKLIST: 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 -GOT TO QUESTION #2: CARRYOVER BETWEEN PATIENT SAMPLES CARRY OVER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975495 ↗
• MalfunctionJul 25, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT SEEING PATIENTS CELL POPULATION WHEN RUN A TUBE WITH ONLY PBS AFTER THE PATIENT SAMPLE/BD FSE IS ONSITE ALREADY AND WORKING ON CROSSOVER ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19830877 ↗
• MalfunctionMar 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER, CONTAMINATION OF A PATIENT SAMPLE OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY CUSTOMER THAT CROSS CONTAMINATION ISSUE. 1.WERE SAMPLES CONTAMINATED? YES. PATIENT SAMPLES CHECKLIST: 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.): NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961579 ↗
• MalfunctionOct 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ 3L10C INSTRUMENT AN "ARM BOARD" ERROR WAS BYPASSED WHILE RUNNING PATIENT SAMPLES. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX SAYS THEY ARE HAVING A PERSISTENT ""ARM BOARD"" ERROR WHERE IT IS PREVENTING RUNNING OF THEIR CLINICAL SAMPLES. 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? ((IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17960840 ↗
• MalfunctionAug 28, 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 FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. CALLED AND SPOKE WITH CUSTOMER AND CUSTOMER STATED THAT THEY WERE PATIENT SAMPLES BUT THEY DETECTED THE ISSUE RIGHT AWAY AND STOPPED USING THIS LYRIC. NO FALSE RESULTS WERE REPORTED TO PATIENTS OR DOCTORS AS A RESULT OF THIS ISSUE. IT WAS REPORTED BY THE CUSTOMER THAT CARRY OVER OF SAMPLES. SIT FLUSH MAY NOT BE FUNCTIONING PROPERLY. NO FALSE RESOLVES WERE REPORTED TO PATIENTS OR DOCTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637991 ↗
• MalfunctionJun 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WAS CARRYOVER INVOLVING PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST -- PATIENT SAMPLES 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.): NO CARRY OVER OF SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139721 ↗
• MalfunctionMay 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WAS CARRYOVER INVOLVING PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER TSR: SINCE THE SIP WAS NOT ASPIRATING WASH FROM THE STINGER AND JUST BACK DRIPPING, I ASKED IF ADJACENT SAMPLES WERE CONTAMINATED FROM CARRY OVER. THE CUSTOMER SAID YES BUT THEY REALIZED THIS WAS HAPPENING AND STOPPED USING THE INSTRUMENT. NO DATA WAS ANALYZED OR RELEASED. I ASKED IF THEY WERE PATIENT SAMPLES AND THE CUSTOMER SAID YES BUT THEY HAD PLENTY OF SAMPLE TO RETAIN AND RUN ON ANOTHER INSTRUMENT. THIS WAS A PRE-CLINICAL STUDY. INSTRUMENT IS GIVING MULTIPLE" VACUUM IS OUT OF RANGE" ERRORS WHILE ACQUIRING SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911110 ↗
• MalfunctionMar 13, 2023Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE 1) THE INFO IN THE WORKLIST WAS DIFFERENT THAN WHAT PRINTED ON THE REPORT. (B)(4). I SPOKE WITH AND SHE INFORMED ME THAT THEY RAN A FEW SAMPLES AND PRINTED THE RESULTS OF ONE PATIENT. THEY NOTICED THE PRINTED RESULTS WERE NOT WHAT THEY EXPECTED. THEY OPENED THE WORKLIST AND NOTICED THE INFO IN THE WORKLIST WAS DIFFERENT THAN WHAT WAS PRINTED. THE VALUES IN THE WORKLIST DATA WAS HIGHER THAT WHAT WAS ON THE PRINTOUT. WHEN THEY WENT INTO THE WORKLIST, THEY DID NOT DO ANYTHING TO CHANGE THE DATA (I.E. MOVE GATES, ETC.). THE CUSTOMER RAN ALL THE SAMPLES A SECOND TIME AND THE RESULTS WERE SIMILAR TO THE FIRST TIME (COMPARING THE 2 WORKLISTS PERFORMED. THE CUSTOMER RAN BLEACH BEFORE AND AFTER EACH RACK OF SAMPLES RUN. THE CALLER WILL BE SENDING PICTURES OF THE ISSUE SHE IS DESCRIBING. THEY WILL BE ATTACHED WHEN I RECEIVE THEM. SHE STATED THERE WILL BE NO PERSONAL PATIENT DATA ON THE INFORMATION SHE SENDS. THE CUSTOMER ALSO MENTIONED THAT SHE CANNOT PRINT ANYTHING AFTER THE WINDOWS UPDATE WAS PERFORMED. HER IT GROUP HAS SOME PROCEDURE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529627 ↗
• MalfunctionFeb 8, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WAS A CARRYOVER ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECTION CARRYOVER IS CONTAMINATING THE SAMPLES. CARRY OVER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318474 ↗
• MalfunctionJun 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ¿IT WAS REPORTED THAT WHILE USING BDB FACSLYRIC THE MALE CONNECTOR ON THE CYTOMETER CRACKED WHERE THE WASTE LINE CONNECTS TO THE BACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565694 ↗
• MalfunctionMar 23, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHEN PLACING DIH20, SOME BLACK, METALLIC, OIL-LIKE DEBRIS WAS NOTICED IN THE BD FACSLYRIC¿ 3L10C INSTRUMENT. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHE PERFORMED A DAILY CLEAN AND WHEN SHE PLACED DIH20 BLACK DEBRIS WAS SEEN. CUSTOMER SAID IT LOOKS LIKE METALLIC OIL. INSTRUMENT JUST HAD A PM DONE ON THE 1ST. ALL PARAMETERS ON FAILING ON BB RCVS. ERROR "LASER DELAY ERROR, CAN NOT REACH APPROPRIATE SCALE WITH MAXIMUM VOLTAGE IN FSC CHANNEL."" "WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870189 ↗
• MalfunctionFeb 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE RUNNING BD FACSLYRIC¿ WASTE LEAKED OUTSIDE OF THE INSTRUMENT. THERE WAS NO PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A POSSIBLE PUMP ISSUE. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? SHEATH. WHAT IS THE SOURCE OF LEAK/SPILL? SAMPLELINE. 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. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588617 ↗
• MalfunctionFeb 14, 2022Contamination; Fluid/Blood Leak; Contamination; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE RUNNING BD FACSLYRIC¿ CARRYOVER OF PATIENT SAMPLES OCCURRED. THE CARRYOVER FLUID ALSO LEAKED OUTSIDE OF THE INSTRUMENT. CUSTOMER WAS EXPOSED TO THE LEAKAGE, HOWEVER, THERE WAS NO NEGATIVE IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SIT LEAKING, CAUSING CARRYOVER 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. ¿WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO¿. ¿YES THE CUSTOMER WAS EXPOSED TO DRIPS OF FLUID THAT WERE ON THE BENCH TOP JUST BENEATH THE SIT. THE AMOUNT OF FLUID THAT DRIPPED WAS APPROXIMATELY 50UL AND THE CONTENTS OF THE FLUID LEAKED IS UNKNOWN PROBABLY MAINLY SHEATH BUT THERE COULD BE CARRY OVER FROM OTHER SAMPLES BUT THE ABSOLUTE CONTENTS OF THE SIT FLUSH COULD BE CATEGORIZED AS UNKNOWN.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529478 ↗
• MalfunctionDec 29, 2021Contamination; Contamination

  IT WAS REPORTED THAT DURING USE WITH A BD FACSLYRIC¿ CARRYOVER WAS OCCURRING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CARRYOVER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112607 ↗
• MalfunctionSep 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE CARRYOVER ISSUES WHILE USING FACSLYRIC 3L10C INSTRUMENT US. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NSS/SR. FSE ONSITE FOR FURTHER INVESTIGATION INTO CARRY OVER ISSUES AFFECTING UP TO ALL THREE LYRICS. TAS ALSO INVOLVED. CARRY OVER ISSUES ONGOING BUT CONTAINED. CARRY ISSUES CONTINUE. CUSTOMER GETTING TENSE. ESCALATION REVIEW WITH NSS AND POA TO FOLLOW. INSTRUMENT REPAIRED AND BACK UP FOR CUSTOMER USE AS OF 8/31. MONITOR THROUGH 9/10 FOR FURTHER ISSUES. SENSITIVE HIGH PROFILE LAB WITH ONE ADDITIONAL LYRIC TO BE DELIVERED/INSTALLED, AND ANOTHER LYRIC PURCHASE TO FOLLOW. THIS INSTRUMENT HAS EXPERIENCED "CARRYOVER" ISSUES FOR THE LAST MONTH. FIRST TIME FIX WAS PINCHED TUBING NEAR VALVE 8. ISSUE HAS COME UP AGAIN. I HAVE INSTRUCTED THE CUSTOMER TO HAVE 3 "SIT FLUSHES" IN BETWEEN SAMPLES TO ENSURE THEIR SAMPLE IS EVACUATED. CUSTOMER RAN SAMPLES FOLLOWED BY TWO DI TUBES TO VERIFY THAT THERE WAS NO CARRYOVER WITHOUT SUCCESS UNTIL THEY IMPLEMENTED THE 3 "SIT FLUSHES". WHAT HAS BEEN REPLACED FROM THE BEGINNING TO TODAY: NEW FLUIDICS BUCKET NEW FLOWCELLNEW SIT ASSEMBLYNEW BARB FITTING ABOVE SIT ASSEMBLYNEW SAMPLE PEEK TUBINGNEW FITTING B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523056 ↗
• MalfunctionSep 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING FACSLYRIC 3L10C INSTRUMENT US LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK CHECKLIST FROM WO. 1) WAS THE LEAK LIQUID OR AIR? LIQUID. 2) WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. 4) WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5) DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? 8) WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? 9) WHAT PERSONAL PROTECTIVE EQUIPMENT WAS BEING USED DURING THE OCCURRENCE? PPE WAS USED. GLOVES WERE WORN. 10) WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO. 11) WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? NO. 12) WHAT IS THE CURRENT MEDICAL STATUS? N/A. PER TSR IN CHATTER ON CASE, NO IMPACT TO PATIENT SAMPLES AS IT WAS NOTICED IN THE MORNING DURING A CLEANING, NO SAMPLES WERE RUN. IT WAS REPORTED BY THE CUSTOMER THAT WHEN THEY WENT TO TURN ON THE MACHINE, THERE WERE RED BLOOD CELLS IN THE TUBE OF WATER. CUSTOMER PROBLEM: THIS MORNIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468286 ↗
• MalfunctionAug 9, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ CARRYOVER OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE HAVING CARRYOVER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12295361 ↗
• MalfunctionJul 6, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿CARRYOVER OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CARRYOVER CAN YOU PLEASE ADVISE IF ANY PATIENT SAMPLES WERE CONTAMINATED? NO THEY WEREN'T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122408 ↗
• MalfunctionMar 19, 2021Contamination; Contamination

  IT WAS REPORTED WHILE USING BD FACSLYRIC¿ CARRYOVER OCCURS WHEN RUNNING SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SIT IS DRIPPING. OCCASIONAL CARRY OVER WHEN RUNNING SAMPLES. CUSTOMER PROBLEM: SIT IS DRIPPING. OCCASIONAL CARRY OVER WHEN RUNNING SAMPLES. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: N/A. NEXT STEPS (IF NECESSARY): DISPATCHING OUT PER THE REQUEST OF THE CUSTOMER. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? N/A. WAS THERE A FLUIDIC LEAK OR SPILL? N/A. 1. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? N/A. 2. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? N/A. 3. WHAT WAS THE FLUID THAT LEAKED/SPILLED? N/A. 4. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) N/A. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N/A. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527118 ↗
• MalfunctionFeb 16, 2021Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD FACSLYRIC¿ THE HOUSING OF THE SIT WAS CRACKED AND WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE LEAK NOT MIXED WITH BLEACH. ARE YOU USING THIS FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. SOFTWARE VERSION? UNKNOWN. LEAK (IF YES EXPLAIN)? NO. LEAK (IF YES EXPLAIN)? WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? SHEATH FLUID. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY SPRAY OF FLUID UNDER PRESSURE? NO. EVERY TIME A SAMPLE IS TESTED AND THE TUBE REMOVED IT ALWAYS DOES A SIT FLUSH. AFTER SPEAKING WITH CUSTOMER, WE DISCOVERED THE SIT FLUSH IS NOT REALLY HAPPENING. ONLY A LARGE DROP IS FORMING AT THE END OF THE SIP WHEN WE DO A SIT FLUSH AND, WHEN HOLDING A TUBE OF WATER ON THE SIT WHILE PERFORMING SIT FLUSH NOTHING IS BEING ASPIRATED. THEY ARE ABLE TO ACQUIRE SAMPLE JUST FINE SO IT DOESN'T APPEAR TO BE A

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

  MAUDE report 11332789 ↗
• MalfunctionFeb 11, 2021Contamination; Fluid/Blood Leak; Contamination; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD FACSLYRIC¿ THE HOUSING OF THE SIT WAS CRACKED SO THE INSTRUMENT WAS NOT PERFORMING THE FLUSH BETWEEN SAMPLES CREATING THE CARRYOVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS A SAMPLE CARRY OVER ISSUE. CUSTOMER PROBLEM: SAMPLE CARRYOVER STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: SEE CASE DESCRIPTION. ARE YOU USING THIS FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. SOFTWARE VERSION? UNKNOWN. LEAK (IF YES EXPLAIN)? NO. LEAK (IF YES EXPLAIN)? 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. 3. WHAT WAS THE FLUID THAT LEAKED? SHEATH FLUID. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 6. WAS THERE ANY SPRAY OF FLUID UNDER PRESSURE? NO. EVERYTIME A SAMPLE IS TESTED AND THE TUBE REMOVED IT ALWAYS DOES A SIT FLUSH. AFTER SPEAKING WITH CUSTOMER, WE DISCOVERED THE SIT FLUSH IS NOT REALLY HAPPENING. ONLY A LARGE DROP IS FORMING AT THE END OF THE SIP WHEN WE DO A SIT

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

  MAUDE report 11316712 ↗
• MalfunctionNov 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT WAS RETESTED ON THE VERITOR AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS, AND WAS THEREFORE USED OFF LABEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4).

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

  MAUDE report 10788311 ↗