The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0034-2013·Announced 2012-10-17

Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Stability Claims

Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

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, but the source text indicates the issue is a labeling update for stability claims to align with standards, with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Beckman Coulter Inc. is recalling CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 reagents, Part Number 6607073. The recall involves 33,259 units total, with 8,458 units distributed in the United States. The product is used for the simultaneous identification and enumeration of lymphocyte percentages and absolute counts in whole blood by flow cytometry.

The recall was initiated because Beckman Coulter determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents need to be updated. The update is necessary for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping.

The affected lots include all tetraCHROME lots manufactured. The product was distributed worldwide, including nationwide in the USA and in numerous other countries. Users should contact Beckman Coulter for further instructions regarding the recall.

The recalled product

Product
CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. 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…
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic
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

Distributed nationwide across the United States.

The notice also names 1 state 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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