ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Summary
The FDA issued a Class III for ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 by Zeiss, Carl Inc. Reason: An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes..
Details
Source
Device Recall
External ID
Z-1465-2022
Action Date
2022-08-03
Status
Terminated
Category
device
Product Description
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Lot/Code Info: UDI-DI: 4064897000075 Serial Number: 3859001079
Quantity Affected: 1 US; 2 OUS
Reason for Recall
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
Distribution
US Nationwide distribution in the state of NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-24
Company
Thornwood, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Zeiss, Carl Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zeiss, Carl Inc have FDA actions?
This is the only FDA action we have on record for Zeiss, Carl Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1465-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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