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U.S. Department of Health and Human Services

Class 2 Device Recall NanoSight NS300

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 Class 2 Device Recall NanoSight NS300see related information
Date Initiated by FirmApril 07, 2022
Create DateAugust 01, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1442-2022
Recall Event ID 90597
Product Classification Particle-size measuring instrument - Product Code REN
ProductNanoSight NS300
Code Information CDRH accession #0510530-003
Recalling Firm/
Manufacturer		 MALVERN PANALYTICAL LTD
Grovewood Road
Malvern United Kingdom
Manufacturer Reason
for Recall		Product found to not comply to Class 1 Laser safety requirement.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionCustomers 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.
Quantity in Commerce507 units
DistributionUS Nationwide - Worldwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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