Reported Jun 11, 2025 · Ongoing
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
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 C11137running software version 1.20
- Lot codes and dates
- UDI-DI15099590732103
- Serial Numbers
231 of 231 codes
300573300572300571300570300569300568300567300566300564300563300562300561300560300559300558300557300556300555300554300553300552300551300548300547300546300544300543300542300541300540300539300538300537300536300535300534300533300532300531300530300528300527300526300525300524300523300522300521300520300519300518300517300516300515300514300512300511300510300509300508
- Amount recalled
- 231 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
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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