Medical device recalls Moderate risk

MALVERN PANALYTICAL LTD recalls NanoSight NS300

Recall date
April 7, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1442-2022
FDA classification
Class II
Brand / firm
MALVERN PANALYTICAL LTD
Sold / distributed
US Nationwide - Worldwide Distribution

Why it was recalled

Product found to not comply to Class 1 Laser safety requirement.

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

What was recalled

NanoSight NS300

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