Reported Apr 12, 2017 · Terminated
UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI…
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 600i SYNCHRON Access Clinical System, Part No. A25637
- A25638 Product UsageThe Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids
- Lot codes and dates
Serial No. (Part No. A25637) 800999801019 Serial No. (Part No. A25638)800995800996800997800998801000801001801002801003801004801005801006801007801008801009801010801011801012801013801014801015801016801017801018801020801021801022801023801024801025801026801027
- Amount recalled
- 851 units total for all products (291 units in US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.
This product could cause temporary or reversible health problems — stop using it.
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