Medical device recalls Moderate risk

LUMINOSTICS, INC dba CLIP HEALTH recalls Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

Recall date
September 2, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0080-2023
FDA classification
Class II
Brand / firm
LUMINOSTICS, INC dba CLIP HEALTH
Sold / distributed
US nationwide distribution

Why it was recalled

COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

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