Reported Feb 14, 2024 · Ongoing
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
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 running software version 1.16 or prior,
- Lot codes and dates
- UDI/DI 15099590732103
- Serial Numbers
127 of 127 codes
300116300117300118300123300127300126300128300129300130300131300133300134300135300136300138300139300137300140300142300141300144300143300145300148 300146300147300149300150300151300152300155300153300154300156300158300160300163300161300162300164300167300170300169300171300168300166300172300176300173300178300181300179300183300182300188300189300190300191300192300195300196
- Amount recalled
- 128 analyzers
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
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or < ) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.
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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