Reported Mar 26, 2025 · Ongoing
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
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 C11137with Component PCBTSI/RSI firmware C29278
- Lot codes and dates
- UDI-DI15099590732103
- Serial Numbers
80 of 80 codes
300158300161300164300167300169300175300178300179300182300183300185300189300194300197300201300202300204300210300216300217300218300220300224300225300233300234300236300237300239300240300241300243300244300246300247300252300255300256300260300267300270300272300273300275300280300288300290300295300296300299300300300304300313300314300317300318300321300322300323300324
- Amount recalled
- 80 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
Why it was recalled
Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting 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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