Reported Aug 29, 2012 · Terminated
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903;…
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. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
UniCel DxC 660i680i860i880i SYNCHRON Access Clinical Systems
- Part NumbersDxC 660i: A64871
- DxC 680iA64903
- DxC 860iA64935
- DxC 880iA59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids
- Lot codes and dates
- Part NumbersDxC 660i: A64871
- DxC 680iA64903
- DxC 860iA64935
- DxC 880iA59102
- Amount recalled
- 2442 units total (784 units in US)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
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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