FDA Recall Open, Classified

NanoSight NS300

Recall: Z-1442-2022 · Initiated April 7, 2022

Recall

Recall Number
Z-1442-2022
Event Number
90597
Firm
MALVERN PANALYTICAL LTD Grovewood Road Malvern United Kingdom
FEI Number
3014373630
Product Code
REN
Status
Open, Classified
Root Cause
Radiation Control for Health and Safety Act
Initiated
April 7, 2022

Description

NanoSight NS300

Reason

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

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.

Distribution

US Nationwide - Worldwide Distribution

Quantity

507 units