The Recall Desk
HighFDA (Devices)·Z-1014-2017·Announced 2017-01-18

Beckman Coulter DxH 600 Cellular Analysis System Recall for Blast Detection

Beckman Coulter is recalling the DxH 600 Cellular Analysis System because it may fail to detect blasts in some blood samples.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for diagnostic error (failure to detect blasts), which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Beckman Coulter Inc. is recalling the DxH 600 Coulter Cellular Analysis System (Catalog No. B23858). The recall involves 1,282 units total, with 915 units distributed in the United States, including Puerto Rico. The product was also distributed to numerous countries worldwide.

The recall was initiated because the system may not flag or detect blasts in some blood samples. Beckman Coulter determined that additional clarification for the Blast Suspect messages is necessary. The company attributes this issue to limitations in the available technology as well as sample limitations.

This recall affects all serial numbers of the affected devices. Healthcare facilities and laboratories using this equipment should contact Beckman Coulter for further instructions on how to manage the recall and ensure patient safety.

The recalled product

Product
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
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)

  • Serial Numbers: All

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 2 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 2 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · diagnostic error

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