Z-1762-2022 Class II Ongoing
FDA device recall Z-1762-2022 was initiated by MALVERN PANALYTICAL LTD on February 28, 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: 76 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- February 28, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 76 units
Product Description
NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Reason for Recall
Product found to not comply to Class 1 Laser safety requirement.
Distribution Pattern
US Nationwide Distribution
Code Information
CDRH accession # 0510530-002