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TRU RSV

MERIDIAN BIOSCIENCE, INC. · Model 751330 · UDI-DI 00840733101847

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510(k) clearances

Adverse events

Recalls

Facilities

Description

TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to be used by clinical laboratories to test specimens from symptomatic patients aged five years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture. The results of this test are used in combination with other clinical tests and the patients’ conditions to diagnose RSV-associated infections.

Recalls

Date	Firm	Reason
2007-03-28	Binax, Inc. dba IMPD	Tip of the foam swab could detach from the shaft causing injury to the patient.
2004-02-18	Binax, Inc.	Pouch integrity compromised
2003-12-15	Becton Dickinson & Co.	Diagnostic test kit may exhibit false positive results.

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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.