Reported Aug 21, 2024 · Ongoing
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #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?
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
- Lot codes and dates
Software versions 1.17 and belowUDI-DI 15099590732103
- Amount recalled
- 183 devices
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
Why it was recalled
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.
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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