Malvern Panalytical Ltd FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
NanoSight NS300Class IIApr 7, 2022Product found to not comply to Class 1 Laser safety requirem	Product found to not comply to Class 1 Laser safety requirement.	Class IIDevices	Apr 7, 2022
NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. sizClass IIFeb 28, 2022Product found to not comply to Class 1 Laser safety requirem	Product found to not comply to Class 1 Laser safety requirement.	Class IIDevices	Feb 28, 2022
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. sizClass IIFeb 28, 2022Product found to not comply to Class 1 Laser safety requirem	Product found to not comply to Class 1 Laser safety requirement.	Class IIDevices	Feb 28, 2022