Reported Mar 13, 2013 · Terminated
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as…
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?
- Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
- Lot codes and dates
- All serial numbers and all software versions 4.05 and prior. Part# Item#
A94907AU5811-02A94912AU5821-02A94917AU5831-02A94922AU5841-02A94908AU5811-03A94913AU5821-03A94918AU5831-03A94923AU5841-03A94909AU5811-04A94914AU5821-04A94919AU5831-04A94924AU5841-04A94910AU5811-06A94915AU5821-06A94920AU5831-06A94925AU5841-06
- All serial numbers and all software versions 4.05 and prior. Part# Item#
- Amount recalled
- 28 in U.S.; 4 Canada; 318 to other foreign countries.
Where it was sold
- Nationwide
Why it was recalled
Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.
This product could cause temporary or reversible health problems — stop using it.
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