Reported Jul 2, 2025 · Ongoing
DxI 9000 Access Immunoassay Analyzer 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 Analyzer C11137
- Lot codes and dates
- UDI-DI 15099590732103 Serial Numbers
246 of 246 codes
300116300124300126300128300132300136300138300144300145300148300150300153300154300155300156300157300158300161300166300168300171300174300175300178300179300182300183300186300190300191300192300193300194300198300200300201300204300205300206300207300208300209300210300211300212300213300214300215300217300218300219300221300225300226300228300231300232300234300235300236
- UDI-DI 15099590732103 Serial Numbers
- Amount recalled
- 67 US; 178 OUS
Where it was sold
Why it was recalled
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
This product could cause temporary or reversible health problems — stop using it.
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