Beckman Coulter AU5800 Chemistry Analyzers Recalled for Leaking C Cups
Beckman Coulter is recalling AU5800 Chemistry Analyzers because cracked C cups can leak coolant onto circuit boards, causing short-circuits and instrument stop mode.
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. The hazard involves equipment malfunction (short-circuit and stop mode) rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving a defect that could lead to adverse consequences but is not immediately life-threatening.
Plain-English summary
Beckman Coulter Inc. is recalling AU5800 Chemistry Analyzers (Reference No. A98352) due to complaints regarding leaking and cracked C cups. The AU series are automated, clinical chemistry analyzers used to measure analytes in patient samples such as serum, plasma, urine, and cerebrospinal fluid.
When a C cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer. This leakage can result in a short-circuit, causing the instrument to go into a stop mode. A total of 2,130 units are affected worldwide, including 588 units in the United States.
The recall covers units distributed nationwide in the US (including Guam and Puerto Rico) and internationally to numerous countries. Users of these analyzers should contact Beckman Coulter for further instructions on how to address the defect.
The recalled product
- Product
- AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other…
- Manufacturer
- Beckman Coulter Inc.
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 (1)
- 1040016
Distribution
Part of a larger recall action
This product is one of 3 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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