BD FACSDuetRecalls & reported problems across all models
Becton, Dickinson And Company · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one BD FACSDuet model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of BD FACSDuet by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2021 and Aug 21, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (1 report).
1 FDA recall record name at least one of these models by its device 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. 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
Reports received per month, all models
BD FACSDuet 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.
- Aug 12, 2024Open, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported BD FACSDuet problems
Device problems
- Contamination1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
BD FACSDuet models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD FACSDuet 663128Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis1 recall1 report
- BD FACSDuet 666340Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis1 recall1 report
Recent BD FACSDuet adverse event reports
The 2 most recent reports across all models, 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 ↗MalfunctionNov 15, 2021Contamination; Contamination
IT WAS REPORTED THAT WHILE RUNNING BD FACSDUET¿ SAMPLE PREP CARRYOVER OCCURRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS CARRY OVER AND CONTAMINATION OF THE ANTIBODIES FROM THE MACHINE. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? N. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12815731 ↗
Other Becton, Dickinson And Company products
- BD Vacutainer SST10 models · 4,985 reports · 3 recalls
- BD Luer-Lok48 models · 5,117 reports
- BD Insyte Autoguard33 models · 4,465 reports · 8 recalls
- BD SafetyGlide17 models · 2,185 reports
- BD Vacutainer Eclipse Blood Collection Needle4 models · 1,880 reports
- BD Vacutainer Push Button Blood Collection Set9 models · 1,831 reports
- BD Nexiva25 models · 1,614 reports · 1 recall
- BD BACTEC MGIT Mycobacteria Growth Indicator Tubes2 models · 1,554 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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