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MRSA/SA ELITe MGB

Elitechgroup Mdx LLC · Model M800346 · UDI-DI 03661540950001

NQX Prescription

510(k) clearances

Adverse events (7 deaths)

Recalls

Facilities

Description

MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Recalls

Date	Firm	Reason
2025-08-06	Cepheid	As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
2019-07-17	Becton Dickinson & Co.	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2019-07-17	Becton Dickinson & Co.	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2019-07-17	Becton Dickinson & Co.	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2019-07-17	Becton Dickinson & Co.	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2017-10-27	Roche 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 infection in the coloni
2016-07-18	Cepheid	Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
2014-07-23	Becton 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 111 MSSA strains tes
2012-05-22	Becton Dickinson & Co.	Leakage in Cepheid SmartCycler reaction tubes.
2011-11-17	Cepheid	Cepheid 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 Xpert MRSA/SA BC (b

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.