NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size
FDA device recall Z-1761-2022 · posted 2022-09-26 · Open, Classified
Recall details
- Recalling firm
- MALVERN PANALYTICAL LTD
- Reason for recall
- Product found to not comply to Class 1 Laser safety requirement.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- REN
- Quantity affected
- 111 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2022-02-28
- Date posted
- 2022-09-26
- Location
- Malvern, United Kingdom
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