Beckman Coulter AU680 Chemistry Analyzers Recalled for Leaking C Cups
Beckman Coulter is recalling AU680 Chemistry Analyzers because leaking and cracked C cups can cause coolant to leak onto circuit boards, resulting in 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) due to coolant leakage, with no reported injuries or deaths in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling AU680 Chemistry Analyzers (Reference No. B04779) 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 the C cups crack, 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 3,084 units are affected, with 713 units distributed in the United States and the remainder distributed internationally.
Healthcare facilities and users of these analyzers should contact Beckman Coulter for further instructions on how to address the defect. The recall is classified as Class II by the FDA.
The recalled product
- Product
- AU680 Chemistry Analyzers, Reference No. B04779 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)
- 1030834
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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