T2Bacteria® Reagent Trays 80-07342Recalls & reported problems
T2 Biosystems, Inc. · The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria panel. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These are the T2 Biosystems T2Bacteria reagent trays, the refrigerated kits of reagents used to run the T2Bacteria panel on the company's blood bacteria detection system. The 35 reports mostly describe the panel returning results that didn't match the patient's lab cultures, such as false positives for organisms like E. coli, K. pneumoniae, P. aeruginosa and E. faecium. None report a death or an injury. There are no recalls naming 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI M70880073423), received between Aug 28, 2023 and Sep 11, 2024 — classified as 35 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (24 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 Result24
- False Negative Result16
Patient problems
- No Clinical Signs, Symptoms or Conditions35
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2024False Negative Result; False Positive Result; False Negative Result; False Positive Result
(B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT THAT THE T2BACTERIA PANEL PRODUCED A DISCORDANT RESULT. THE T2BACTERIA PANEL PRODUCED A POSITIVE P. AERUGINOSA RESULT COMPARED TO POSITIVE BLOOD CULTURE AND URINE CULTURE RESULTS FOR S. AUREUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20188928 ↗MalfunctionAug 13, 2024False Positive Result; False Positive Result
18 JULY 2024: T2BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE P. AERUGINOSA RESULT USING THE T2BACTERIA PANEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19971213 ↗MalfunctionAug 7, 2024False Positive Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19927401 ↗MalfunctionAug 7, 2024False Positive Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE E. FAECIUM RESULT USING THE T2BACTERIA PANEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19927360 ↗MalfunctionAug 7, 2024False Negative Result; False Positive Result; False Negative Result; False Positive Result
(B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2BACTERIA PANEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19927318 ↗MalfunctionAug 7, 2024False Negative Result; False Positive Result; False Negative Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT THAT THE T2BACTERIA PANEL PRODUCED A DISCORDANT RESULT. THE T2BACTERIA PANEL PRODUCED A POSITIVE K. PNEUMONIAE RESULT COMPARED TO A POSITIVE BLOOD CULTURE RESULT FOR E. COLI.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19927287 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE E. COLI RESULT USING THE T2BACTERIA PANEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19923567 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE P. AERUGINOSA RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19923179 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE P. AERUGINOSA RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19923104 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
ON (B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2 BACTERIA PANEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19922627 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19922348 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2BACTERIA PANEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19922318 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE E. COLI RESULT USING THE T2BACTERIA PANEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19922172 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
ON (B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2 BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19922151 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
(B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE E. COLI RESULT USING THE T2BACTERIA PANEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19922034 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
ON 8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE E. COLI RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921875 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
ON 8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2BACTERIA PANEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921592 ↗MalfunctionAug 6, 2024False Positive Result; False Positive Result
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE E. COLI RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921582 ↗MalfunctionAug 6, 2024False Negative Result; False Negative Result
ON (B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE NEGATIVE E. COLI RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19918133 ↗MalfunctionMay 7, 2024False Negative Result; False Negative Result
ON (B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE NEGATIVE E. COLI RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19258526 ↗MalfunctionApr 5, 2024False Negative Result; False Negative Result
ON (B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE NEGATIVE E. FAECIUM RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19053484 ↗MalfunctionApr 5, 2024False Positive Result; False Positive Result
(B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19050570 ↗MalfunctionApr 5, 2024False Positive Result; False Positive Result
(B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE E. COLI RESULT USING THE T2BACTERIA PANEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19050529 ↗MalfunctionJan 26, 2024False Negative Result; False Negative Result
(B)(6) 2023: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT THAT THE T2BACTERIA PANEL PRODUCED A DISCORDANT RESULT. THE T2BACTERIA PANEL PRODUCED A "TARGET NOT DETECTED" RESULT COMPARED TO A POSITIVE BLOOD CULTURE RESULT FOR E.COLI.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18588688 ↗MalfunctionJan 26, 2024False Negative Result; False Negative Result
(B)(6) 2023: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT THAT THE T2BACTERIA PANEL PRODUCED A DISCORDANT RESULT. THE T2BACTERIA PANEL PRODUCED A "TARGET NOT DETECTED" RESULT COMPARED TO A POSITIVE BLOOD CULTURE RESULT FOR S. AUREUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18588675 ↗
Other Direct Blood Bacterial Nucleic Acid Detection System devices
- T2Bacteria® Reagent Trays 80-08072T2 Biosystems, Inc. · Direct Blood Bacterial Nucleic Acid Detection System4 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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