BD FACSDuet 663128Recalls & reported problems
Becton, Dickinson And Company · BD FACSDuet Sample Prep US · 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 00382906631282), received between Nov 15, 2021 and Nov 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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.
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
- Contamination1
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.
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 ↗
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- 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.
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