BD MAX™ ExK™ DNA-1 442817Recalls & reported problems
Becton, Dickinson And Company · BD MAX™ ExK™ DNA-1 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382904428174), received between Jul 21, 2021 and May 15, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Jul 17, 2019Class IITerminated
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Z-2323-2019 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- False Positive Result2
- Incorrect, Inadequate or Imprecise Result or Readings2
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.
MalfunctionMay 15, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING KIT BD MAX EXK DNA-1 USA THERE WAS A FALSE POSITIVE RESULT OBTAINED FOR ANAPLASMA. CONFIRMATORY REPEAT TESTING WAS PERFORMED AND THE RESULT WAS NEGATIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22030791 ↗MalfunctionMay 15, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING KIT BD MAX EXK DNA-1 USA THERE WAS A FALSE POSITIVE RESULT OBTAINED FOR ANAPLASMA. CONFIRMATORY REPEAT TESTING WAS PERFORMED AND THE RESULT WAS NEGATIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22030283 ↗MalfunctionNov 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING THE BD MAX¿ EXK¿ DNA-1 KIT DISCREPANT RESULTS WERE OBTAINED. RESULTS WERE CORRECTED AFTER REPEAT TESTING AND NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18172259 ↗MalfunctionJul 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING 5 BD MAX¿ EXK¿ DNA-1 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MAX 442817_1089873 E. FEACALIS CONTAMINATION;".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12207491 ↗
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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 · 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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