Summary
The FDA issued a Class II for NanoSight NS300 by MALVERN PANALYTICAL LTD. Reason: Product found to not comply to Class 1 Laser safety requirement..
Details
Source
Device Recall
External ID
Z-1442-2022
Action Date
2022-08-10
Status
Ongoing
Category
device
Product Description
NanoSight NS300
Lot/Code Info: CDRH accession #0510530-003
Quantity Affected: 507 units
Reason for Recall
Product found to not comply to Class 1 Laser safety requirement.
Distribution
US Nationwide - Worldwide Distribution
Type: FDA Mandated
Recall Initiated: 2022-04-07
Company
Malvern, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 97 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MALVERN PANALYTICAL LTD has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MALVERN PANALYTICAL LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MALVERN PANALYTICAL LTD have FDA actions?
MALVERN PANALYTICAL LTD has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1442-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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