BD MAX™ MRSA 442953Recalls & reported problems
Geneohm Sciences Canada Inc · BD MAX™ MRSA · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
3 other recalls cover devices cleared under the same FDA submission (K120138); 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.
Recalls naming this device
- Jul 17, 2019Terminated
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Z-2328-2019 · Root cause: Process control · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K120138. 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
- Z-2618-2014 · Jul 23, 2014 · TerminatedThe BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from
Other SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN devices
- BD MAX™ MRSA XT 443461Becton, Dickinson And Company · SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN1 recall9 reports
- Xpert SA Nasal Complete GXSACOMP-10Cepheid · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen1 recall0 reports
- Gram-Positive Blood Culture (BC-GP) Utility Tray 20-011-018Nanosphere, Inc. · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen1 recall0 reports
- Gram-Positive Blood Culture (BC-GP) Utility Tray 20-011-018Luminex Corporation · SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN1 recall0 reports
- Xpert MRSA/SA Blood Culture GXMRSA/SA-BC-10Cepheid · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen2 deaths6 reports
- Xpert MRSA NxG GXMRSA-NXG-10Cepheid · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen1 death1 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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