Medical device recalls Moderate risk

MALVERN PANALYTICAL LTD recalls NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. siz…

Recall date
February 28, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1761-2022
FDA classification
Class II
Brand / firm
MALVERN PANALYTICAL LTD
Sold / distributed
US Nationwide 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 LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).

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