Z-0785-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2024
- Initiation Date
- December 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 112 units
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.
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,
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