FDA Enforcement
Class II
Ongoing
NanoSight NS300
Recall: Z-1442-2022
·
Reported August 10, 2022
Enforcement
- Recall Number
- Z-1442-2022
- Event ID
- 90597
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MALVERN PANALYTICAL LTD
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- August 10, 2022
- Initiation Date
- April 7, 2022
- Classification Date
- August 1, 2022
- Address
- Grovewood Road, N/A, Malvern, N/A, N/A, United Kingdom
Description
NanoSight NS300
Reason
Product found to not comply to Class 1 Laser safety requirement.
Code Info
CDRH accession #0510530-003
Distribution
US Nationwide - Worldwide Distribution
Quantity
507 units