BD MAX™ ExK™ DNA-3 442821Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382904428211), received between Jun 17, 2021 and May 14, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination” (2 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025False Positive Result; False Positive Result

  IT WAS REPORTED WHEN USING KIT BD MAX EXK DNA-3 USA DISCREPANT RESULTS WERE OBTAINED FOR C. AURIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021913 ↗
• MalfunctionJul 13, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED WHILE TESTING WITH THE BD MAX¿ EXK¿ DNA-3 INSTRUMENT PROTEUS SP. CONTAMINATION WAS PRESENT WITH LOT#: 1306435. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE HAVING ISSUES WITH THE LOT#: 1306435. ISSUE IS PROTEUS SP. CONTAMINATION OF THE KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009061 ↗
• MalfunctionMay 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MAX¿ EXK¿ DNA-3 THE CUSTOMER OBSERVED BIOLOGICAL CONTAMINATION OF SEVERAL KITS. THIS EVENT OCCURRED 2 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS WIDESPREAD CONTAMINATION ACROSS SEVERAL KITS OF 442821 - LOT #2025615.", "I CAN CONFIRM THAT THE NEW LOT (2025615) WAS POSITIVE FOR ENTEROCOCCUS FAECALIS IN TWO REPLICATE WATER BLANK SAMPLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14350237 ↗
• MalfunctionNov 16, 2021False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ EXK¿ DNA-3 FALSE POSITIVE RESULTS WERE OBTAINED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER HAS NOT RESPONDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSISTENT POSITIVE RESULTS WITH EACH TEST ON THIS LOT#.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822087 ↗
• MalfunctionOct 15, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING 10 BD MAX¿ EXK¿ DNA-3CLINICAL SAMPLE CONCENTRATOR 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: " ¿ CUSTOMER PROBLEM: RECEIVED 10 KITS FROM LOT NUMBER WITH A KNOWN E. FEACALIS CONTAMINATION ISSUE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639961 ↗
• MalfunctionJun 23, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING 25 BD MAX¿ EXK¿ DNA-3 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: " CUSTOMER ALLEGES THE KITS BEING A SOURCE OF E. FAECALIS CONTAMINATION OF THEIR RUNS"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12052005 ↗
• MalfunctionJun 17, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING BD MAX¿ EXK¿ DNA-3 FALSE POSITIVE RESULTS 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: " CUSTOMER REPORTS THAT REPLACEMENT RECEIVED UNDER CASE (B)(4). IS ALSO POSITIVE FOR E. FAECALIS "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12019110 ↗