Z-1761-2022Class II

NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics...

Name: Z-1761-2022 NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics...
Creator: Malvern Panalytical Ltd
Published: 2022-02-28
License: https://open.fda.gov/license/

Malvern Panalytical Ltd / initiated 2022-02-28 / Open, Classified

FDA source

MALVERN PANALYTICAL LTD began a recall of NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size) on 2022-02-28. FDA classified it as Class II and gives the reason as "Product found to not comply to Class 1 Laser safety requirement". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1761-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-28
Posted: 2022-09-26
Recalling firm: Malvern Panalytical Ltd
Product: NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Product code: REN Particle-Size Measuring Instrument
Reason for recall: Product found to not comply to Class 1 Laser safety requirement.
FDA root cause: Radiation Control for Health and Safety Act
Action: Customers are being made aware of this issue. Malvern Panalytical will retrofit modified microscope plates and cell tops with a new safety cover on the LM10 to maintain the original Class 1 laser product classification at no charge to the purchaser.
Quantity in commerce: 111 units
Distribution: US Nationwide Distribution
Product codes and lots: CDRH accession # 0510530-001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1761-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1761-2022	Class II	Ongoing	FDA Mandated	2022-10-05	2022-09-26
Z-1762-2022	Class II	Ongoing	FDA Mandated	2022-10-05	2022-09-26

Product code REN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)