Recall Z-1762-2022— MALVERN PANALYTICAL LTD

Class II · Ongoing

Class II FDA medical device recall by MALVERN PANALYTICAL LTD, initiated 2022-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm
MALVERN PANALYTICAL LTD
Classification
Class II
Status
Ongoing
Initiated
2022-02-28
Firm location
Malvern, N/A, United Kingdom

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.