BD MAX™ GBS 441772Recalls & reported problems
Becton, Dickinson And Company · BD MAX™ GBS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
The BD MAX GBS is a laboratory system that tests patient samples directly for group B streptococcus. Most of the 37 reports describe results that came back positive when culture testing showed the patient was negative, along with a few inaccurate or missing results and one report involving an injury. There were no deaths. No recalls name this device. Reports of these result problems have risen sharply, from 2 in the earlier 12-month period to 13 in the most recent one.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00382904417727), received between Mar 22, 2021 and Sep 22, 2026 — classified as 1 injury, 37 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (33 reports).
7 other recalls cover devices cleared under the same FDA submission (K111860); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result33
- Incorrect, Inadequate or Imprecise Result or Readings3
- False Negative Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858505 ↗MalfunctionAug 18, 2026False Positive Result
It was reported that during use of BD MAX¿ GBS, a discrepant patient result was obtained.Initial test was GBS Positive, but the repeat test was GBS negative.Result was confirmed to be GBS negative by culture.There was no report of patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303780 ↗MalfunctionApr 29, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE NEGATIVE PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. SAMPLE WAS SENT OUT FOR UNSPECIFIED CONFIRMATORY TESTING AND WAS NEGATIVE FOR GBS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028887 ↗MalfunctionApr 13, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS CULTURED AND WAS GROUP B STREPTOCOCCUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857257 ↗MalfunctionApr 13, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS CULTURED AND WAS GROUP B STREPTOCOCCUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857056 ↗MalfunctionApr 13, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS CULTURED AND WAS GROUP B STREPTOCOCCUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857049 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822989 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822987 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822985 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822574 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822560 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822559 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822558 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822557 ↗MalfunctionOct 15, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302817 ↗MalfunctionOct 15, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302765 ↗MalfunctionSep 17, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED AND THE RESULT WAS GBS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20241668 ↗MalfunctionSep 5, 2024False Positive Result; False Positive Result
REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE GBS PATIENT RESULT WAS OBTAINED. REPEAT TESTING WAS PERFORMED ON MAX FROM A NEW SAMPLE, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20145860 ↗MalfunctionSep 5, 2024False Positive Result; False Positive Result
REPORT 1 OF 2: IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE GBS PATIENT RESULT WAS OBTAINED. REPEAT TESTING WAS PERFORMED ON MAX FROM A NEW SAMPLE, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20145827 ↗MalfunctionApr 17, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ GBS ASSAY, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 5 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127262 ↗MalfunctionApr 17, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ GBS ASSAY, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 1 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127047 ↗MalfunctionApr 17, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ GBS ASSAY, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 3 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127032 ↗MalfunctionApr 17, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ GBS ASSAY, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 4 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127028 ↗MalfunctionApr 17, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ GBS ASSAY, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 2 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127025 ↗MalfunctionApr 1, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ GBS, A FALSE POSITIVE RESULT WAS OBTAINED. A CONFIRMATORY CULTURE WAS PERFORMED AND RESULTED AS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19013475 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K111860. 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-1004-2025 · Dec 19, 2024 · Open, ClassifiedBD PCR Cartridges used with MAX System. Model Number: 437519
- Z-0590-2025 · Oct 31, 2024 · Open, ClassifiedBD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
- Z-1864-2017 · Jul 29, 2015 · TerminatedSoftware version 4.44A utilized on the BD MAX System
- Z-1662-2013 · May 31, 2013 · TerminatedBD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification a
- Z-0976-2013 · Dec 11, 2012 · TerminatedBD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada
- Z-0701-2013 · Sep 18, 2012 · TerminatedBecton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Other Nucleic acid amplification assay system, group b streptococcus, direct specimen test devices
- Alethia™ Group B Streptococcus 480350Meridian Bioscience, Inc. · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1 recall0 reports
- Xpert GBS LB GXGBS-LB-10Cepheid · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test2 reports
- illumigene Group B Streptococcus 280350Meridian Bioscience, Inc. · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1 report
- Xpert GBS GXGBS-100N-10Cepheid · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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