FDA Enforcement
Class II
Ongoing
NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Recall: Z-1762-2022
·
Reported October 5, 2022
Enforcement
- Recall Number
- Z-1762-2022
- Event ID
- 90835
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MALVERN PANALYTICAL LTD
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- October 5, 2022
- Initiation Date
- February 28, 2022
- Classification Date
- September 26, 2022
- Address
- Grovewood Road, N/A, Malvern, N/A, N/A, United Kingdom
Description
NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Reason
Product found to not comply to Class 1 Laser safety requirement.
Code Info
CDRH accession # 0510530-002
Distribution
US Nationwide Distribution
Quantity
76 units