Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall
Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software data storage limitation that may prevent saving of certain sample results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software data storage limitation that may affect result accuracy, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling the AU5800 Clinical Chemistry Analyzer, an automated device used to measure analytes such as Glucose, Magnesium, and Potassium. The recall involves 28 units in the United States, 4 in Canada, and 318 in other foreign countries, distributed worldwide.
The recall is due to a software data storage limitation that occurs under certain conditions. When this issue occurs, 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 affects all serial numbers and software versions 4.05 and prior.
Affected units are identified by specific part and item numbers listed in the recall documentation. Users should contact Beckman Coulter Inc. for further instructions regarding the software limitation.
The recalled product
- Product
- Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
- Manufacturer
- Beckman Coulter Inc.
Distribution
Distributed nationwide across the United States.
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