MALVERN PANALYTICAL LTD Grovewood Road Malvern United Kingdom NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Brand
MALVERN PANALYTICAL LTD Grovewood Road Malvern United Kingdom
Lot Codes / Batch Numbers
CDRH accession # 0510530-001
Products Sold
CDRH accession # 0510530-001
MALVERN PANALYTICAL LTD Grovewood Road Malvern United Kingdom is recalling NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle chara due to Product found to not comply to Class 1 Laser safety requirement.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product found to not comply to Class 1 Laser safety requirement.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026