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.
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 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…
- Manufacturer
- Beckman Coulter Inc.
- 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)
- Not applicable
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighBeckman Coulter AU5800 Clinical Chemistry Analyzer Recalled for Software Error
FDA (Devices) · 2013-05-01
- LowBeckman Coulter AU5800 Clinical Chemistry Analyzer Recall for Labeling Defect
FDA (Devices) · 2013-08-14
- HighBeckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall
FDA (Devices) · 2025-05-07
- HighBeckman Coulter Recalls AU2700 and AU5400 Clinical Chemistry Analyzers
FDA (Devices) · 2013-06-05
- ModerateBeckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall
FDA (Devices) · 2013-08-07
- ModerateBeckman Coulter AU5800 Chemistry Analyzers Recalled for Leaking C Cups
FDA (Devices) · 2016-08-10