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Recall Observatory FDA recall evidence

Device product

NanoSight NS300

Z-1442-2022

April 07, 2022

Class II

Product summary

Firm
MALVERN PANALYTICAL LTD
Event
Event 90597
Status
Ongoing
Classification
Class II
Quantity
507 units
Official record key
device-enforcement:Z-1442-2022

Official wording

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

Code information: CDRH accession #0510530-003

Distribution pattern: US Nationwide - Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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