Device product
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
Z-0785-2024
Product summary
- Event
- Event 93655
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 112 units
- Official record key
device-enforcement:Z-0785-2024
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: 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,
Derived failure modes
-
Unknown
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.