Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall
Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software error causing concentrated wash solution pump failures and leaks.
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 mechanical leak/overflow rather than a direct patient safety risk or reported injury, fitting the moderate severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling 76 units of the AU5800 Clinical Chemistry Analyzer with Automation Ready Connection. The affected model numbers are AU5811, AU5821, AU5831, and AU5841, and the recall includes all software versions. These in vitro diagnostic systems were distributed worldwide, including in the United States, China, Italy, Japan, Canada, Turkey, the United Kingdom, Singapore, Israel, and the Netherlands.
The recall was initiated because Beckman Coulter identified a software error on AU5800 analyzers equipped with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, which creates an overflow or leak on each analyzer unit.
Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to resolve the software error and manage the affected equipment.
The recalled product
- Product
- 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.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 76
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Numbers: AU5811-01
- AU5821-01
- AU5831-01
- AU5841-01
- AU5811-02
- AU5821-02
- AU5831-02
- AU5841-02
- AU5811-03
- AU5821-03
- AU5831-03
- AU5841-03
- AU5811-04
- AU5821-04
- AU5831-04
- AU5841-04
- AU5811-06
- AU5821-06
- AU5831-06
- AU5841-06 Part Numbers: A94906
Distribution
Distributed nationwide across the United States.
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