Ongoing Class II Medical devices
- Recall started
- 7 April 2022
- Reason
- Product found to not comply to Class 1 Laser safety requirement.
- Distribution
- US Nationwide - Worldwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-1442-2022
- NanoSight NS300
Malvern, N/A, United Kingdom
MALVERN PANALYTICAL LTD recalls
2 recalls recorded since 2018, most recently on 7 April 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 February 2022
- Reason
- Product found to not comply to Class 1 Laser safety requirement.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall numbers
- Z-1761-2022, Z-1762-2022
- NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
- NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.