MALVERN PANALYTICAL LTD: Product found to not comply to Class 1 Laser safety requirement.

Agency Publication Date: September 26, 2022

Affected Products

Product: NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).

CDRH accession # 0510530-001

Product: NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).

CDRH accession # 0510530-002

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90835

Status: Active

Manufacturer: MALVERN PANALYTICAL LTD

Manufactured In: United Kingdom

Units Affected: 2 products (111 units; 76 units)

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Sources: FDA iRES · Raw API Response

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Medium RiskFDA Device