Z-1762-2022 Class II Ongoing

Recalled by MALVERN PANALYTICAL LTD — Malvern, N/A

Recall Details

Product Type
Devices
Report Date
October 5, 2022
Initiation Date
February 28, 2022
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
76 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide Distribution

Code Information

CDRH accession # 0510530-002