Reported Jun 18, 2025 · Ongoing
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 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 versions 1.20
- Lot codes and dates
- UDI-DI15099590732103
- Serial Numbers
224 of 224 codes
300144300145300148300150300153300154300155300156300157300158300161300166300168300171300174300175300178300182300183300186300190300191300192300193300194300198300200300201300204300205300206300208300209300210300211300212300213300214300215300217300218300219300221300225300226300228300231300232300234300235300236300240300242300249300250300252300255300266300267300270
- Amount recalled
- 324 units
Where it was sold
- Nationwide
Why it was recalled
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation 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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