BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials 442021Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials · Class 1
All models of BD BACTEC Lytic/10 Anaerobic/F Culture Vials (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BACTEC Lytic/10 Anaerobic/F culture vial has 777 FDA reports, including 761 malfunctions, 15 injuries and 1 death. Most reports describe false positive results, where blood cultures wrongly signal growth, along with contamination and occasional false negatives. There are no recalls naming this device. Reports fell from 165 in the previous 12 months to 11 in the most recent 12 months.
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
- 791
- Deaths reported
- 1
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 791 adverse event reports that list this exact device (DI 00382904420215), received between Feb 4, 2021 and Sep 30, 2026 — classified as 1 death, 15 injuries, 775 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (598 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 Positive Result598
- Incorrect, Inadequate or Imprecise Result or Readings102
- False Negative Result42
- Contamination32
- Leak/Splash11
- Contamination of Device Ingredient or Reagent7
- Device Markings/Labelling Problem5
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions782
- Insufficient Information7
- No Consequences Or Impact To Patient2
- Bacterial Infection1
- Sepsis1
Recent adverse event reports
The 25 most recent of 791 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950614 ↗MalfunctionSep 30, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950608 ↗MalfunctionSep 30, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947256 ↗MalfunctionSep 30, 2026False Negative Result
It was reported that while using BD BACTEC¿ Lytic/10 Anaerobic/F Culture Vials (plastic), an unspecified number of false-negative results were obtained. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947252 ↗MalfunctionSep 30, 2026False Negative Result
It was reported that while using BD BACTEC¿ Lytic/10 Anaerobic/F Culture Vials (plastic), an unspecified number of false-negative results were obtained. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947251 ↗MalfunctionSep 30, 2026False Negative Result
It was reported that while using BD BACTEC¿ Lytic/10 Anaerobic/F Culture Vials (plastic), an unspecified number of false-negative results were obtained. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947249 ↗MalfunctionSep 30, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947246 ↗MalfunctionSep 30, 2026False Negative Result
It was reported that while using BD BACTEC¿ Lytic/10 Anaerobic/F Culture Vials (plastic), an unspecified number of false-negative results were obtained. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947244 ↗MalfunctionSep 30, 2026False Negative Result
It was reported that while using BD BACTEC¿ Lytic/10 Anaerobic/F Culture Vials (plastic), an unspecified number of false-negative results were obtained. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947243 ↗MalfunctionSep 30, 2026False Negative Result
It was reported that while using BD BACTEC¿ Lytic/10 Anaerobic/F Culture Vials (plastic), an unspecified number of false-negative results were obtained. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947241 ↗MalfunctionSep 30, 2026False Negative Result
It was reported that while using BD BACTEC¿ Lytic/10 Anaerobic/F Culture Vials (plastic), an unspecified number of false-negative results were obtained. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947220 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938139 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938128 ↗MalfunctionAug 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302060 ↗MalfunctionAug 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253457 ↗MalfunctionAug 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253456 ↗MalfunctionApr 3, 2026Leak/Splash
IT WAS REPORTED AFTER USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778462 ↗MalfunctionApr 1, 2026Leak/Splash
IT WAS REPORTED AFTER USING BD BACTEC¿ LYTIC/10 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 24755854 ↗MalfunctionMar 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MIS ASSOCIATION OF ONE PATIENT SAMPLE NUMBER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498660 ↗MalfunctionMar 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MIS ASSOCIATION OF ONE PATIENT SAMPLE NUMBER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496259 ↗MalfunctionFeb 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS NIALLIA CIRCULANS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343809 ↗MalfunctionFeb 5, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WERE TWO FALSE NEGATIVE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24271882 ↗MalfunctionFeb 5, 2026Contamination
REPORT 3: IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268598 ↗MalfunctionFeb 5, 2026Contamination
REPORT 1: IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268592 ↗MalfunctionJan 27, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WERE TWO FALSE NEGATIVE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189691 ↗
Other SYSTEM, BLOOD CULTURING devices
- BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1,472 reports
- BD BACTEC™ Plus Aerobic/F Culture Vials 442023Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING2 deaths1,063 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™ Plus Anaerobic/F Culture Vials 442022Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING237 reports
- BD BACTEC™ MGIT™ 960 Instrument 445870Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING186 reports
- BACT/ALERT® FA PLUSBiomerieux , Inc. · System, blood culturing1 recall126 reports
- BACT/ALERT® PF PLUSBiomerieux , Inc. · System, blood culturing1 recall124 reports
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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