The Recall Desk
ModerateFDA (Devices)·Z-1704-2017·Announced 2017-04-12

Beckman Coulter Recalls AU680 and AU5800 Rack ID Labels Due to Mismatch

Beckman Coulter is recalling Rack ID Labels for AU680 and AU5800 analyzers because the displayed ID number and barcode do not match.

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 a labeling mismatch (displayed ID vs. barcode) without reported injuries, fitting the criteria for moderate severity.

Plain-English summary

Beckman Coulter Inc. is recalling Rack ID Labels (Catalog No. MU907400) used with the AU680 and AU5800 Clinical Chemistry Analyzers. The recall is being conducted because the Rack ID number displayed on the label and the Rack ID barcode label do not match.

The affected product consists of 2 sheets containing 20 labels per sheet. These labels are intended for use with the automated chemistry analyzers, which measure analytes in samples for in vitro diagnostic use.

The recall covers units distributed in Massachusetts and internationally to Japan. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the defect.

The recalled product

Product
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibra

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)

  • Not applicable

Distribution

Distributed in 1 state: