NanoSight particle analyzer recalled for laser safety non-compliance
Malvern Panalytical is recalling approximately 111 NanoSight LM10 instruments with LM12 modules nationwide due to non-compliance with Class I laser safety requirements. Users may be exposed to unsafe laser radiation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is an FDA Class II recall of a risk-of-harm product (non-compliant laser equipment) where no injuries have been reported. Class I laser safety non-compliance represents a genuine occupational hazard to laboratory users, but without reported injury or hospitalization, it meets the threshold for Score 3 per the rubric.
Plain-English summary
Malvern Panalytical Ltd is recalling approximately 111 NanoSight LM10 fitted with LM12 module laboratory instruments distributed nationwide in the United States. These instruments are particle analysis devices used to determine particle characteristics such as size.
The instruments were found to not comply with Class I laser safety requirements. This safety standard non-compliance means the equipment does not meet federal requirements for safe laser operation, which could potentially expose laboratory users to hazardous laser radiation.
The recall affects all units within the nationwide distribution. Laboratories and research facilities using this equipment should discontinue use and contact Malvern Panalytical for instructions on remediation or replacement.
Users who have questions or believe they have been affected should contact Malvern Panalytical Ltd or the FDA. The recall number is Z-1761-2022.
The recalled product
- Product
- NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
- Manufacturer
- MALVERN PANALYTICAL LTD
- Hazard
- Affected units
- 111
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 # 0510530-001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by MALVERN PANALYTICAL LTD under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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