BD FACSDuet 666340Recalls & reported problems
Becton, Dickinson And Company · BD FACSDuet™ Premium Sample Preparation System · Class 1
All models of BD FACSDuet (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382906663405), received between Aug 21, 2024 and Aug 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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.
Reports received per month
Recalls naming this device
- Aug 12, 2024Class IIOpen, Classified
Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.
Z-0009-2025 · Root cause: Software change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT WHILE USING BD FACSDUET USER BYPASSED ERROR MESSAGE. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT ASPIRATION ERRORS. 1. IS THIS FACSPRESTO OR FACSCOUNT? IF YES, NO FURTHER QUESTIONS REQUIRED. IF NO, GO TO QUESTION #2.: NO. 2. DID THE INSTRUMENT DISPLAY AN ERROR MESSAGE? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.: YES. 3. WHAT ERROR MESSAGE WAS DISPLAYED? (PROVIDE ERROR CODE AND/OR DESCRIPTION) GO TO QUESTION #4.: ERROR DISPENSING LYSE. 4. DID YOU RUN A DIAGNOSTIC PATIENT ASSAY WITHOUT RESOLVING THE ERROR MESSAGE? IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, GO TO QUESTION #5 AND THEN GO TO PATIENT SAMPLES CHECKLIST.: YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20010307 ↗
Other Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis devices
- FACS 647205Becton, Dickinson And Company · Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis123 reports
- Sample Preparation System PS-10Sysmex Corporation · Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis1 recall3 reports
- BD FACSDuet 663128Becton, Dickinson And Company · Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis1 recall1 report
- Cellmek C44603Beckman Coulter, Inc. · Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis1 recall0 reports
- PrepPlus 2 378600Beckman Coulter, Inc. · Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page