Class 2 Device Recall NanoSight LM10

• Date Initiated by Firm: February 28, 2022
• Date Posted: September 26, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1761-2022
• Recall Event ID: 90835
• Product Classification: Particle-size measuring instrument - Product Code REN
• Product: NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
• Code Information: CDRH accession # 0510530-001
• 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: Radiation Control for Health and Safety Act
• Action: Customers are being made aware of this issue. Malvern Panalytical will retrofit modified microscope plates and cell tops with a new safety cover on the LM10 to maintain the original Class 1 laser product classification at no charge to the purchaser.
• Quantity in Commerce: 111 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC 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.