Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Summary
The FDA issued a Class II for Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C7694 by Beckman Coulter, Inc.. Reason: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the c.
Details
Source
Device Recall
External ID
Z-0784-2024
Action Date
2024-01-31
Status
Ongoing
Category
device
Product Description
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Lot/Code Info: C49513, UDI/DI 15099590748647; C76947, UDI/DI 15099590748654; All serial numbers
Quantity Affected: 254 units
Reason for Recall
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Distribution
US and Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland,
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-19
Company
Miami, FL
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 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
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 (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0784-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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