FDA Medical Device Recalls (openFDA)
MALVERN PANALYTICAL LTD: NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
- Recall number
- Z-1761-2022
- Recalling firm
- MALVERN PANALYTICAL LTD
- Product
- NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
- Status
- Open, Classified
- Initiated
- 2022-02-28
- Posted
- 2022-09-26
- Terminated
- not on file
- Reason
- Product found to not comply to Class 1 Laser safety requirement.
- 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
- 111 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- CDRH accession # 0510530-001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REN
- Firm FEI
- 3014373630
- Firm city
- Malvern
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28