BD FACSLyric 662875Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382906628756), received between Sep 30, 2021 and Sep 18, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Contamination” (6 reports).

1 FDA recall record 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-0745-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionSep 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING USAGE OF BD FACSLYRIC¿ CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CARRY OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089541 ↗
• MalfunctionApr 25, 2025Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER, THE CUSTOMER ENCOUNTERED CARRYOVER INVOLVING PATIENT SAMPLES. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "BLOOD ON THE TUBE IS EXPOSE TO DI WATER. HAPPENING FOR A WHILE. FSE ALREADY VISIT SEVERAL TIMES.¿ 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. CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. BLOOD ON THE TUBE IS EXPOSE TO DI WATER. 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. NO. 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 QU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912729 ↗
• MalfunctionApr 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING USE WITH A BD FACSLYRIC¿ INSTRUMENT CARRYOVER OCCURRED AND A FALSE POSITIVE RESULT WAS OBTAINED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE GETTING CARRY OVER FROM ONE SAMPLE TO THE NEXT. IF THE FIRST SAMPLE IS POSITIVE AND THE SECOND SAMPLE IS TO BE NEGATIVE, IT IS COMING UP POSITIVE FROM CELL INFILTRATES FROM THE POSITIVE FIRST TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868586 ↗
• MalfunctionFeb 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT SAMPLE CARRYOVER WAS OBSERVED DURING USE WITH THE BD FACSLYRIC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST : 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.: CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST: BACKFLUSH/SAMPLE CARRYOVER IN THE WATER TUBE WITH RESIDUAL BLOOD. BACKFLUSH/SAMPLE CARRYOVER IN THE WATER TUBE WITH RESIDUAL BLOOD AFTER SHUTDOWN YESTERDAY. IT HAPPENS WHEN THE MACHINE IS SITTING IDLE AND BLOOD CAN BE SEEN IN TUBE ON THE SIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446077 ↗
• MalfunctionDec 22, 2023Incorrect, 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 FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. IT WAS REPORTED BY THE CUSTOMER THAT ACQUISITION TOO FAST (1.7X). TALKED WITH CX. CX SAYS THIS LYRIC IS ASPIRATING SAMPLE MORE VOLUMETRICALLY THAN THE OTHER LYRIC IN THE LAB. THE ISSUE IS MOST NOTABLE USING 96 WELL PLATES AND NOT WITH SAMPLE TUBES. CX GUESSED THE INCREASED VOLUMETRIC RATE IS 1.7 TIMES FASTER THAN THE OTHER LYRIC. PQC PASSES WITHOUT ISSUE. THE EVENT RATE DOESN'T SEEM TO BE INCREASED BUT THEY SEEM TO RUN OUT OF SAMPLE WHEN ASPIRATING/ COLLECTING USING A 96 WELL PLATE. I ASKED IF THEY COMPARED THE 96 WELL PLATES AFTER ACQUISITION BETWEEN THIS INSTRUMENT AND THE OTHER LYRIC TO SEE IF MAYBE THIS LY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383030 ↗
• MalfunctionNov 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USING BD FACSLYRIC¿ ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT ABSOLUTE VALUES TRENDING HIGH FOR CD3,CD8,CD45 TRUCOUNT ASSAY. CX SAYS THE ABSOLUTE NUMBERS ARE TOO HIGH FOR THE IVD CD3,CD8,CD45 TRUCOUNT ASSAY. CX HAS TRIED A NEW LOT OF CSANDT BEADS AND TRIED GOING BACK TO THE OLD CSANDT BEAD LOT AND FINDS THE ABSOLUTE NUMBERS FOR THIS TEST IS STILL TRENDING UPWARD. CX HAS BEEN USING CALIBRATED PIPETTES AND ALSO TRYING REVERSE PIPETTE TECHNIQUES. CX USES THIS INSTRUMENT FOR CLINICAL SAMPLES BUT THE TRENDS WERE NOTICED ON NORMAL CONTROLS. CX SAYS THIS ISSUE MAY OF IMPACTED SOME CLINICAL SAMPLES. ABSOLUTE VALUES TRENDING HIGH FOR CD3,CD8,CD45 TRUCOUNT ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066338 ↗
• MalfunctionJul 28, 2023Incorrect, 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 CARRYOVER BETWEEN PATIENT SAMPLES HAD OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT SPILLOVER SEEN IN SAMPLES. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTION S REQUIRED.): NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421343 ↗
• MalfunctionOct 27, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC THAT THERE HAVE BEEN CARRYOVER ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTS THAT THERE HAVE BEEN ISSUES AFTER THE LASER PM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15683492 ↗
• MalfunctionNov 8, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE RUNNING FACSLYRIC¿ CARRYOVER OCCURRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE CARRY OVER CONCERNS. PATIENT SAMPLES CHECKLIST FROM CASE. 1) ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? NO. 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 12775226 ↗
• MalfunctionSep 30, 2021Contamination; Contamination

  IT WAS REPORTED WHEN USING THE BY THE BD FACSLYRIC¿ FLOW CYTOMETER THERE WERE CARRYOVER ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE REPORTER: THE CUSTOMER IS EXPERIENCING CARRY OVER WITH BOTH THE TUBES AS WELL AS PLATES ON THE LOADER. CUSTOMER STATED RECENTLY AND SUCCESSFULLY THERE WAS RESOLVEMENT OF THEIR PREVIOUS ISSUE BUT NOW THEY ARE SEEING CARRYOVER ONLY ON THIS INSTRUMENT, THEIR OTHER LYRIC IS NOT EXPERIENCING ANY CARRYOVER ISSUES. CARRYOVER ISSUES OCCURRING WITH TUBE RACKS AS WELL AS WELL PLATES." NO REPORTED ERRONEOUS RESULTS ON PATIENT SAMPLES FROM THE DIAGNOSTIC TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558122 ↗