Beckman Coulter Recalls TetraCXP Software for Labeling Updates
Beckman Coulter is recalling TetraCXP software and CYTO-STAT reagents to update specimen stability claims in the product labeling.
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 involves a labeling error regarding stability claims. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity level.
Plain-English summary
Beckman Coulter Inc. is recalling the TetraCXP Software System (Part Number A40051) and associated CYTO-STAT reagents. The recall involves 146 units total, with 37 units distributed in the United States and the remainder distributed worldwide. The affected products are used for lymphocyte immunophenotyping in whole blood.
The recall was initiated because Beckman Coulter determined that the specimen and prepared sample stability claims stated in the product labeling need to be updated. The update is necessary for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping. The recall covers all tetraCHROME lots manufactured.
Healthcare facilities and laboratories that have purchased these products should contact Beckman Coulter for further instructions regarding the labeling update.
The recalled product
- Product
- TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow…
- 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)
- All tetraCHROME lots manufactured
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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