FDAClass IIJanuary 31, 2024

REV 2 Flowcell Capsule Spare recall

REV 2 Flowcell Capsule Spare, Part Number: C04154

Why was REV 2 Flowcell Capsule Spare recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI15099590689452, All lot numbers

Product
REV 2 Flowcell Capsule Spare, Part Number: C04154
Recalling firm
Beckman Coulter, Inc.
Quantity
16 units
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,
Recall date
January 31, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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