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Open, Classified

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

FDA Recall Z-1761-2022 · Posted 2022-09-26

Recalling FirmMALVERN PANALYTICAL LTD
Recall StatusOpen, Classified
Product CodeREN
Date Initiated2022-02-28
Product Quantity111 units

Reason for Recall

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

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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