BD MAX™ System Refurb 441927Recalls & reported problems
Becton, Dickinson And Company · Instrument Max Clinical Refurb · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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 00382904419271), received between Mar 2, 2022 and Jul 2, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Sep 23, 2025Open, Classified
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Z-0238-2026 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- False Negative Result1
- False Positive Result1
- Structural Problem1
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.
MalfunctionJul 2, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, THE DOOR WOULD NOT STAY OPEN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19661335 ↗MalfunctionAug 15, 2022False Negative Result; False Negative Result
IT WAS REPORTED THAT WHILE USING BD MBD MAX¿ INSTRUMENT, REMANUFACTURED IT ACQUIRED FALSE NEGATIVES ON PATIENT SAMPLES. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FALSE NEGATIVES ON PATIENT SAMPLES".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15225544 ↗MalfunctionAug 1, 2022False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC PARASITE PANEL THERE WAS DISCREPANT RESULTS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED DISCREPANT RESULTS ON 7/8, GIARDIA WAS POSITIVE AND ON 7/10 REPEATED DUPLICATES WERE NEGATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15140924 ↗MalfunctionMar 2, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BD MAX¿ INSTRUMENT, REMANUFACTURED HAD INCORRECT LABEL INFORMATION. THE FOLLOWING FIELDS WERE CORRECTED WITH ADDITIONAL INFORMATION: "IT WAS REPORTED BY THE CUSTOMER THAT THE BOX WAS LABELED CORRECTLY WITH THE INCORRECT PART INSIDE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13656881 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.