Reported Feb 5, 2020 · Terminated
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700-…
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. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- iQ200 Series Urine Microscopy Analyzer
- Catalog numbers
700-3345700-3375700-3325700-3347700-3300RFB700- 3320700-3320RFB700-3322700-3322RFB700-3326700- 3340700-3370B48999C10683
- C10684 - Product Usagedevice used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis
- Lot codes and dates
- UDI
10837461001317108374610013551083746100125610837461001300All Part Numbers
- UDI
- Amount recalled
- 6601 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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