Reported Mar 26, 2025 · Ongoing
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
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. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
DxI 9000 Access Immunoassay AnalyzerCatalog Number C11137
- Lot codes and dates
- UDI-DI15099590732103
- Serial Numbers
300116-300117300123-300124300126300128-300139300141-300145300147- 300158300160-300164300166-300179300181-300183300186300188-300195300197-300207300209-300250300252- 300256300258-300259300261300263- 300264300266-300277300279-300290300291300293-300299300300-300309300312-300352
- Amount recalled
- 206 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient 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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