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System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

FDA product code NQX · Class 2 · Microbiology

29
Registered devices
56
Adverse events
20
Recalls
24
510(k) clearances

Devices with this code

BD GeneOhm™ MRSA ACP Assay (48 tests) — Geneohm Sciences Canada IncGram-Positive Blood Culture (BC-GP) Utility Tray — LUMINEX CORPORATIONXpert MRSA/SA SSTI — CEPHEIDXpert SA Nasal Complete — CEPHEIDBD MAX™ StaphSR — BECTON, DICKINSON AND COMPANYBD MAX™ System — BECTON, DICKINSON AND COMPANYBD GeneOhm™ MRSA ACP Lysis Kit — Geneohm Sciences Canada IncBD MAX™ MRSA XT — BECTON, DICKINSON AND COMPANYXpert MRSA NxG — CEPHEIDXpert MRSA — CEPHEIDGram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge — LUMINEX CORPORATIONBD GeneOhm™ StaphSR assay 48 TestsA — Geneohm Sciences Canada IncLightCycler® Advanced Lysis — Roche Molecular Systems, Inc.Xpert SA Nasal Complete — CEPHEIDXpert MRSA — CEPHEIDARIES® MRSA Assay — LUMINEX CORPORATIONcobas® MRSA/SA Controls and Cofactor Kit — Roche Molecular Systems, Inc.BD GeneOhm™ MRSA ACP Assay — Geneohm Sciences Canada IncGram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge — NANOSPHERE, INC.cobas® MRSA/SA Test — Roche Molecular Systems, Inc.Xpert MRSA NxG — CEPHEIDMRSA/SA ELITe MGB — Elitechgroup Mdx LLCGram-Positive Blood Culture (BC-GP) Extraction Tray — NANOSPHERE, INC.BD MAX™ MRSA — Geneohm Sciences Canada Inc

Recent recalls

DateFirmReason
2025-08-06CepheidAs a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
2019-07-17Becton Dickinson & Co.The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2019-07-17Becton Dickinson & Co.The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2019-07-17Becton Dickinson & Co.The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2019-07-17Becton Dickinson & Co.The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2017-10-27Roche Molecular Systems, Inc.The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential inf
2016-07-18CepheidInternal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
2014-07-23Becton Dickinson & Co.The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of
2012-05-22Becton Dickinson & Co.Leakage in Cepheid SmartCycler reaction tubes.
2011-11-17CepheidCepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.