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Recall Observatory FDA recall evidence

Device product

iQ Waste Well Adapter, Part Number: 700-3393

Z-0787-2024

December 19, 2023

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 93655
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0787-2024

Official wording

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 cannula has the potential to generate erroneous results.

Code information: UDI/DI 15099590706180, all lot numbers

Distribution pattern: 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,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.