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Gram-Positive Blood Culture (BC-GP) Utility Tray

NANOSPHERE, INC. · Model 20-011-018 · UDI-DI 00857573006287

NQX PAM Prescription

510(k) clearances

Adverse events (7 deaths)

Recalls

Facilities

Description

The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).

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.