FDAClass IIOctober 5, 2022

NanoSight LM10 fitted with LM12 module. A laboratory recall

NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).

Why was NanoSight LM10 fitted with LM12 module. A laboratory recalled?

Product found to not comply to Class 1 Laser safety requirement.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

CDRH accession # 0510530-001

Product
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Recalling firm
MALVERN PANALYTICAL LTD
Quantity
111 units
Distribution
US Nationwide Distribution
Recall date
October 5, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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