BD MAX™ ExK™ TNA-3 442827Recalls & reported problems
Becton, Dickinson And Company · BD MAX™ ExK™ TNA-3 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904428273), received between Jul 28, 2020 and Jul 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE PATIENT HAD A SECOND TEST PERFORMED AT ANOTHER FACILITY AND THAT RESULT WAS NEGATIVE. THE PATIENT HAD A PROLONGED HOSPITAL STAY DUE TO THE ERRONEOUS RESULT. EUA#: (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10335415 ↗
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- EZ2 Connect MDx 9003230QIAGEN GmbH · Clinical Sample Concentrator1 recall0 reports
- BD MAX™ ExK™ DNA-2 442819Becton, Dickinson And Company · CLINICAL SAMPLE CONCENTRATOR1 recall0 reports
- BD MAX™ ExK™ TNA-2 442825Becton, Dickinson And Company · CLINICAL SAMPLE CONCENTRATOR1 recall0 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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