Z-1442-2022 Class II Ongoing
FDA device recall Z-1442-2022 was initiated by MALVERN PANALYTICAL LTD on April 7, 2022 and is designated Class II. Reason for recall: Product found to not comply to Class 1 Laser safety requirement. The recall status is ongoing. Affected quantity: 507 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2022
- Initiation Date
- April 7, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 507 units
Product Description
NanoSight NS300
Reason for Recall
Product found to not comply to Class 1 Laser safety requirement.
Distribution Pattern
US Nationwide - Worldwide Distribution
Code Information
CDRH accession #0510530-003