Reported Feb 12, 2025 · Completed
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
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?
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
- Lot codes and dates
- UDI/DI 15099590732103
- serial numbers
61 of 61 codes
300208300201300184300185300169300225300175300172300221300209300211300212300213300214300215300210300174300226300204300216300217300170300220300176300188300199300200300177300222300224300173300181300202300191300223300171300186300190300203300178300195300189300198300227300228300168300194300205300206300207300197300218300179300182300192300219300193300183300180300187
- Amount recalled
- 61 units
Where it was sold
- Nationwide
Why it was recalled
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
This product could cause temporary or reversible health problems — stop using it.
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