FDA Recall
Open, Classified
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Recall: Z-1761-2022
·
Initiated February 28, 2022
Recall
- Recall Number
- Z-1761-2022
- Event Number
- 90835
- 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
- February 28, 2022
- Posted
- September 26, 2022
Description
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Reason
Product found to not comply to Class 1 Laser safety requirement.
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.
Distribution
US Nationwide Distribution
Quantity
111 units