T2Bacteria® Reagent Trays 80-08072Recalls & reported problems
T2 Biosystems, Inc. · The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M70880080723), received between Mar 11, 2024 and Dec 6, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2024False Negative Result; False Negative Result
7 NOVEMBER 2024: T2BIOSYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A SUSPECTED CLINICAL FALSE NEGATIVE E. COLI RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20867792 ↗MalfunctionOct 24, 2024False Negative Result; False Negative Result
ON 26 SEPTEMBER 2024: T2BIOSYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A SUSPECTED CLINICAL FALSE NEGATIVE P. AERUGINOSA RESULT USING THE T2BACTERIA PANEL..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20522417 ↗MalfunctionOct 18, 2024False Negative Result; False Negative Result
(B)(6) 2024: T2BIOSYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A SUSPECTED CLINICAL FALSE NEGATIVE E. COLI RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20486485 ↗MalfunctionMar 11, 2024False Negative Result; False Negative Result
(B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT THAT THE T2BACTERIA PANEL PRODUCED A NEGATIVE RESULT COMPARED TO A POSITIVE BLOOD CULTURE RESULT FOR PSEUDOMONAS AERUGINOSA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18880588 ↗
Other Direct Blood Bacterial Nucleic Acid Detection System devices
- T2Bacteria® Reagent Trays 80-07342T2 Biosystems, Inc. · Direct Blood Bacterial Nucleic Acid Detection System35 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 16, 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