BD MAX™ CPO 445262Recalls & reported problems
Becton, Dickinson And Company · Kit BD MAX CPO · Class 2
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00382904452629), received between Mar 7, 2024 and Jan 20, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (16 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result16
- False Positive Result5
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CHECK-POINTS (CPO), A FALSE POSITIVE VERONA INTEGRON-ENCODED METALLO-B-LACTAMASE (VIM) PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. CULTURE WAS POSITIVE, AND IMMUNOCHROMATOGRAPHY SHOWED VIM. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117634 ↗MalfunctionNov 13, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CHECK-POINTS (CPO), AN NDM FALSE POSITIVE PATIENT RESULT WITH A FLAT PCR CURVE WAS OBTAINED. ANOTHER UNSPECIFIED PCR ASSAY GAVE NDM NEGATIVE RESULTS, AND CULTURE WAS ALSO NDM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23545036 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CHECK-POINTS (CPO), A FALSE NEGATIVE VIM PATIENT RESULT WAS OBTAINED. CULTURED SAMPLE WAS VIM POSITIVE BY IMMUNOCHROMATOGRAPHY. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544985 ↗MalfunctionNov 13, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CHECK-POINTS (CPO), A FALSE NEGATIVE VIM PATIENT RESULT WAS OBTAINED. CULTURED SAMPLE WAS VIM POSITIVE BY IMMUNOCHROMATOGRAPHY. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544983 ↗MalfunctionSep 19, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. THE CULTURE WAS POSITIVE, AND IMMUNOCHROMATOGRAPHY YIELDED VIM. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100533 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066944 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066940 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE OXA PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066934 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066931 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066930 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066928 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066927 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE OXA PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066926 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. THE CULTURE WAS POSITIVE, AND IMMUNOCHROMATOGRAPHY YIELDED VIM. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066925 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. THE CULTURE WAS POSITIVE, AND IMMUNOCHROMATOGRAPHY YIELDED VIM. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066922 ↗MalfunctionSep 16, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE OXA PATIENT RESULT WAS OBTAINED. THE CULTURE WAS POSITIVE, AND IMMUNOCHROMATOGRAPHY YIELDED OXA. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066920 ↗MalfunctionJul 31, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE POSITIVE NDM PATIENT RESULT WAS OBTAINED. SAMPLE TESTED POSITIVE FOR THE NDM TARGET, ALTHOUGH THE PCR CURVE DOES NOT SHOW A CLEAR SIGMOID SHAPE AND THE CT IS VERY HIGH. SAMPLE TESTED NEGATIVE FOR THE OXA48 AND VIM/IMP TARGETS, WHILE THE AMPLIFICATION CURVES SHOW A CLEAR SIGMOID SHAPE AND A CT OF AROUND 35. SAMPLE WAS THEN CULTURED, WHICH CONFIRMED THE POSITIVE RESULT FOR NDM AND THE NEGATIVE RESULTS FOR OXA-48 AND VIM/IMP. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22678013 ↗MalfunctionMay 13, 2025False Positive Result; False Positive Result
REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD MAX¿ CHECK-POINTS (CPO), AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012836 ↗MalfunctionJan 21, 2025False Positive Result; False Positive Result
REPORT 1 OF 2: IT WAS REPORTED THAT DURING USE OF BD MAX¿ CHECK-POINTS (CPO), AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200968 ↗MalfunctionOct 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO ASSAY, A DISCREPANT PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FIRST TEST GAVE A POSITIVE RESULT FOR OXA-48. THE SECOND TEST GAVE AN OXA-48 NEGATIVE RESULT BUT CURVE WAS VISIBLE. THE THIRD TEST GAVE ANOTHER OXA-48 POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20356164 ↗MalfunctionJul 19, 2024False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX CPO, A FALSE NEGATIVE VIM/IMP PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19781871 ↗MalfunctionMar 7, 2024False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD MAX CPO THE USER RECEIVED A POSITIVE RESULT FOR BOTH KPC AND OXA-48, HOWEVER UPON REPEAT ONLY OXA-48 WAS CONFIRMED POSITIVE BASED ON GRAPHICAL DATE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856324 ↗
Other System, nucleic acid amplification test, DNA, antimicrobial resistance marker, direct specimen devices
- BD MAX Check-Points CPO 278102Check-Points Health B.V. · System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.