Reported Oct 29, 2025 · Ongoing
DxI 9000 Access Immunoassay Analyzer, Part 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 AnalyzerPart Number C11137
- Lot codes and dates
- C11137 UDI-DI15099590732103
- Serial Numbers
571 of 571 codes
300621300655300564300572300411300425300576300577300625300295300713300714300289300497300333300520300524300440300443300441300444300445300528300515300332300466300484300412300395300541300255300270300499300435300436300467300532300560300600300604300605300607300609300610300707300709300710300596300597300374300679300677300558300559300593300584300169300239300124300225
- Amount recalled
- 571 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
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
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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