The Recall Desk
ModerateFDA (Devices)·Z-2308-2016·Announced 2016-08-10

Beckman Coulter Recalls AU480 Chemistry Analyzers Due to Leaking C Cups

Beckman Coulter is recalling AU480 Chemistry Analyzers because leaking C cups can cause coolant to short-circuit the instrument's circuit boards.

What this means for you

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 equipment malfunction (short-circuit/stop mode) rather than direct physical injury or death to patients.

Plain-English summary

Beckman Coulter Inc. is recalling AU480 Chemistry Analyzers (Reference No. B28624) 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) inside the analyzer. This leakage can result in a short-circuit, causing the instrument to enter a stop mode. A total of 3,355 units are affected, with 617 units distributed in the United States and the remainder distributed internationally.

Users of these analyzers should contact Beckman Coulter for instructions on how to address the defect. The recall is classified as Class II by the FDA.

The recalled product

Product
AU480 Chemistry Analyzers, Reference No. B28624 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 access
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Clinical Chemistry Analyzer
Hazard

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)

  • 1030647

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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.

See all 3 products in this recall →

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