BD MAX™ Cdiff (US) 443418Recalls & reported problems
Becton, Dickinson And Company · BD MAX™ Cdiff (US) · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382904434182), received between Jun 14, 2024 and Jun 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K130470); they may or may not involve this specific model.
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
- Incorrect, Inadequate or Imprecise Result or Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 2: IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ CDIFF, A POSITIVE C. DIFFICILE PATIENT RESULT WAS OBTAINED. SAMPLE WAS RERUN ON SAME MAX INSTRUMENT, AND GAVE A NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19537349 ↗MalfunctionJun 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 2: IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ CDIFF, A POSITIVE C. DIFFICILE PATIENT RESULT WAS OBTAINED. SAMPLE WAS RERUN ON SAME MAX INSTRUMENT, AND GAVE A NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19537110 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K130470. One submission often covers many models, so check the product and lot details in each record.
- Z-0238-2026 · Sep 23, 2025 · Open, ClassifiedBD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
- Z-0590-2025 · Oct 31, 2024 · Open, ClassifiedBD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Other C.Difficile toxin gene amplification assay devices
- Revogene C. difficile 410300Meridian Bioscience, Inc. · C. Difficile Toxin Gene Amplification Assay1 recall0 reports
- Clostridium difficile (CDF) Stool Sample Preparation Kit 30-002-022Luminex Corporation · C. Difficile toxin gene amplification assay1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.