BD BACTEC™ Plus Anaerobic/F Culture Vials 442022Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ Plus Anaerobic/F Culture Vials, Case of 50 vials · Class 1
All models of BD BACTEC Plus Anaerobic/F Culture Vials (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BACTEC Plus vial is a bottle used for blood culture testing. The 237 reports mostly describe results that missed germs or wrongly flagged them, yeast contamination in samples and blood leaking from bottles, and some tie missed germs to expired vials. The reports include 4 injuries and no deaths, and reports rose to 98 in the last 12 months from 29 in the 12 months before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 237
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 30382904420223), received between Feb 8, 2021 and Jul 29, 2026 — classified as 4 injuries, 233 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (97 reports).
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
Most reported problems
Device problems
- False Negative Result97
- False Positive Result58
- Incorrect, Inadequate or Imprecise Result or Readings35
- Contamination25
- Device Markings/Labelling Problem7
- Leak/Splash7
- Inaccurate Information2
- Contamination of Device Ingredient or Reagent1
Patient problems
- No Clinical Signs, Symptoms or Conditions231
- No Consequences Or Impact To Patient2
- Sepsis2
- Fever1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 237 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2026Device Ingredient or Reagent Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072955 ↗MalfunctionApr 29, 2026False Negative Result
ONE (1) FALSE NEGATIVE RESULT FOR ACINETOBACTER BAUMANNII WAS REPORTED AFTER THE USE OF EXPIRED BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC). THE ISSUE WAS ATTRIBUTED TO USER ERROR. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034194 ↗MalfunctionApr 29, 2026False Negative Result
ONE (1) FALSE NEGATIVE RESULT FOR PSEUDOMONAS AERUGINOSA WAS REPORTED AFTER THE USE OF EXPIRED BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC). THE ISSUE WAS ATTRIBUTED TO USER ERROR. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034173 ↗MalfunctionMar 24, 2026Leak/Splash
IT WAS REPORTED AFTER USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC), BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675500 ↗MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION IDENTIFIED AS YEAST SEEN IN TEN SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177264 ↗MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION IDENTIFIED AS YEAST SEEN IN AN UNSPECIFIED QUANTITY OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177263 ↗MalfunctionJan 8, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION IDENTIFIED AS YEAST SEEN IN ONE SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24002474 ↗MalfunctionDec 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23818811 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 63 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543625 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 74 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543624 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 58 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543621 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 59 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543620 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 57 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543619 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 60 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543618 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 62 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543613 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 61 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543612 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 55 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543611 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 56 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543610 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 54 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543609 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 52 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543604 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 53 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543603 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 51 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543601 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 50 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543600 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 84 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543469 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 88 OF 90.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543468 ↗
Other SYSTEM, BLOOD CULTURING devices
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- BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials 442021Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1 death791 reports
- BD BACTEC™ FX Top 441385Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING2 recalls1 death475 reports
- BD BACTEC™ Peds Plus™/F Culture Vials 442020Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING355 reports
- BD BACTEC™ MGIT™ 960 Instrument 445870Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING186 reports
- BACT/ALERT® FA PLUSBiomerieux , Inc. · System, blood culturing1 recall126 reports
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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
- 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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