Beckman Coulter Recalls Access CEA Assay Reagent Packs for Filling Errors
Beckman Coulter is recalling Access CEA Assay reagent packs because they were filled incorrectly. The recall covers 11,406 units distributed worldwide.
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 source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a manufacturing error (incorrect filling) rather than a high-risk pathogen or structural defect, fitting the criteria for a moderate severity score.
Plain-English summary
Beckman Coulter Inc. is recalling the Access CEA Assay, Part No. 33200, which is used for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum. The recall is being conducted because the reagent packs were filled incorrectly.
The recall involves 11,406 units total. The affected products were distributed nationwide in the United States and in numerous countries worldwide, including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. The specific lot codes associated with this recall are 595027 and 595029.
This recall is classified as Class II by the U.S. Food and Drug Administration. Healthcare facilities and laboratories should stop using the affected reagent packs and contact Beckman Coulter for instructions on how to return the product.
The recalled product
- Product
- Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
- 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)
- 595027 595029
Distribution
Distributed nationwide across the United States.
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