Reported Jan 31, 2024 · Ongoing
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683,…
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 11800 Sw 147th Ave · Miami, FL · 33196-2500
Is this the product you have?
- iQ200 Series Urine Microscopy Analyzers
- Part Numbers
a) 700-3320b) 700-3370c) 700-3345d) 700-3347e) C10683f) 700-3375g) 700-3325h) C10684
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 10837461001188700-3320, UDI/DI 10837461001188 2 10837461001324700-3370, UDI/DI 10837461001324 3 10837461001300700-3345, UDI/DI 10837461001300 4 10837461001317700-3347, UDI/DI 10837461001317 5 15099590697129C10683, UDI/DI 15099590697129 6 10837461001355700-3375, UDI/DI 10837461001355 7 10837461001256700-3325, UDI/DI 10837461001256 8 15099590695484C10684, UDI/DI 15099590695484; All serial numbers - Amount recalled
- 112 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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