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Open, Classified

NanoSight NS300

FDA Recall Z-1442-2022 · Posted None

Recalling FirmMALVERN PANALYTICAL LTD
Recall StatusOpen, Classified
Product CodeREN
Date Initiated2022-04-07
Product Quantity507 units

Reason for Recall

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

Firm Action

Customers are being made aware of this issue. All affected customers will be provided with a remediation kit with Class 3R labels and manual addenda with revised safety instructions.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide - Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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