iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-33...
FDA Recall #Z-0785-2024 — Class II — December 19, 2023
Product Description
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
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.
Recalling Firm
Beckman Coulter, Inc. — Miami, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
112 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,
Code Information
a) 700-3320, UDI/DI 10837461001188; b) 700-3370, UDI/DI 10837461001324; c) 700-3345, UDI/DI 10837461001300; d) 700-3347, UDI/DI 10837461001317; e) C10683, UDI/DI 15099590697129 f) 700-3375, UDI/DI 10837461001355; g) 700-3325, UDI/DI 10837461001256; h) C10684, UDI/DI 15099590695484; All serial numbers
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated