Reported May 24, 2023 · Ongoing
iQ200 Series Urine Microscopy Analyzer
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 Analyzer
4 of 4 products
| Model / number | Product as published |
|---|---|
| — | iQ 200 Select, Part Numbers C10684 and 700-3345 |
| — | iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis |
700-3347 | iQ200 Select 1500 |
700-3325 | iQ200 Sprint |
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published — 1509959069548410837461001300iQ 200 Select, Part Numbers C10684, UDI/DI 15099590695484 and 700-3345, UD/DI 10837461001300 — 1509959069712910837461001355iQ 200 Elite, Part Numbers C10683, UDI/DI 15099590697129 and 700-3375, UDI/DI 10837461001355 700-334710837461001317iQ200 Select 1500, , UD/DI 10837461001317 700-332510837461001256iQ200 Sprint, , UDI/DI 10837461001256; All analyzers with Windows 10, Software Version 8.1 - Amount recalled
- 1068 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 of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated.
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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