Reported Aug 7, 2013 · Terminated
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811,…
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?
- AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
- Lot codes and dates
- Model Numbers
AU5811-01AU5821-01AU5831-01AU5841-01AU5811-02AU5821-02AU5831-02AU5841-02AU5811-03AU5821-03AU5831-03AU5841-03AU5811-04AU5821-04AU5831-04AU5841-04AU5811-06AU5821-06AU5831-06
- AU5841-06 Part Numbers
A94906A94911A94916A91921 A94907A94912A94917A94922 A94908A94913A94918A94923 A94909A94914A91949A94924 A94910A94915A94920
- A94925 Serial NumbersAll
- Model Numbers
- Amount recalled
- 76 units
Where it was sold
- Nationwide
Why it was recalled
The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
This product could cause temporary or reversible health problems — stop using it.
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