BD FACSLyricRecalls & reported problems across all models

We found 4 models of BD FACSLyric by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Nov 4, 2020 and Sep 18, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Contamination” (16 reports).

5 FDA recall records name at least one of these models by its device identifier, 4 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

BD FACSLyric 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. Nov 1, 2024Open, 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. Nov 1, 2024Open, 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-0747-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Nov 1, 2024Open, 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-0746-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Nov 1, 2024Open, 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 ↗

5. Jan 2, 2019Terminated

   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 BD FACSLyric problems

BD FACSLyric models

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

• BD FACSLyric 662878

  Flow cytometric reagents and accessories.
  2 recalls23 reports
• BD FACSLyric 662875

  Flow cytometric reagents and accessories.
  1 recall10 reports
• BD FACSLyric 662877

  Flow cytometric reagents and accessories.
  1 recall1 report
• BD FACSLyric 662876

  Flow cytometric reagents and accessories.
  1 recall0 reports

Recent BD FACSLyric adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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