Beckman Coulter, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0785-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 19, 2023

Date Posted: January 31, 2024

Recall Number: Z-0785-2024

Event ID: 93655

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.

Status: Ongoing

Product Quantity: 112 units

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

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,

Voluntary or Mandated:

Voluntary: Firm initiated