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Alethia™ Pertussis External Control Kit

MERIDIAN BIOSCIENCE, INC. · Model 479930 · UDI-DI 00840733102141

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.

Recalls

Date	Firm	Reason
2025-03-24	Ortho-Clinical Diagnostics, Inc.	It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
2019-02-20	Luminex Corporation	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially

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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.