NanoSight NS300 Medical Device Recalled for Laser Safety Noncompliance
Malvern Panalytical is recalling 507 NanoSight NS300 units due to noncompliance with Class 1 laser safety requirements. The device may not meet established safety standards for laser-based instruments.
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: This recall receives a severity score of 3 (High) because the NanoSight NS300 represents a risk-of-harm product with no injuries reported to date. The noncompliance with Class 1 Laser safety requirements poses potential hazards to users without evidence of current harm.
Plain-English summary
Malvern Panalytical Ltd is recalling 507 units of the NanoSight NS300, a particle analysis instrument. The FDA recall number is Z-1442-2022.
The product does not comply with Class 1 Laser safety requirements, which establish standards for safe operation of laser-based instruments. This noncompliance poses a potential risk to device users.
The affected units were distributed nationwide in the United States and internationally to customers worldwide. Users who own or operate a NanoSight NS300 should discontinue use and contact Malvern Panalytical Ltd for further instructions regarding the recall.
The recalled product
- Product
- NanoSight NS300
- Manufacturer
- MALVERN PANALYTICAL LTD
- Category
- Medical Device
- Hazard
- Affected units
- 507
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 #0510530-003
Distribution
Distributed nationwide across the United States.
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