Laboratory Instrument Recalled for Class 1 Laser Safety Non-Compliance
Malvern Panalytical is recalling 76 NanoSight LM10 laboratory instruments that do not comply with Class 1 laser safety requirements. The company is taking this action to prevent potential laser exposure risks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for laser safety non-compliance. While no injuries have been reported, laser safety violations represent a risk-of-harm product that could cause serious eye injuries to laboratory personnel, warranting a High severity rating.
Plain-English summary
Malvern Panalytical Ltd. is recalling 76 NanoSight LM10 laboratory instruments fitted with LM14 modules. These instruments are used in laboratory settings to measure particle characteristics such as size.
The instruments were found to not comply with Class 1 laser safety requirements. This non-compliance creates a potential risk of laser exposure to users.
The affected instruments were distributed nationwide in the United States. Laboratory facilities and research institutions that use these instruments may be affected.
Owners of the affected NanoSight LM10 instruments should contact Malvern Panalytical Ltd. immediately for instructions on how to address the laser safety non-compliance. Do not use these instruments until the issue has been resolved.
The recalled product
- Product
- NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
- Manufacturer
- MALVERN PANALYTICAL LTD
- Hazard
- laser-safety
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- CDRH accession # 0510530-002
Distribution
Distributed nationwide across the United States.
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