The Recall Desk
HighFDA (Devices)·Z-1384-2019·Announced 2019-05-29

Beckman Coulter UniCel DxH 900 Hematology Analyzer Recall for Platelet Errors

Beckman Coulter is recalling 341 UniCel DxH 900 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.

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 high-risk diagnostic error where a critical condition (thrombocytopenia) may go unrecognized, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Beckman Coulter Inc. is recalling 341 units of the UniCel DxH 900 Coulter Cellular Analysis System (REF number C11478). The recall is due to complaints of sporadic erroneously elevated platelet results that occur without flags or system messages. This defect may cause thrombocytopenia (low platelet count) to go unrecognized in patient testing.

The affected devices are distributed worldwide, including US nationwide (including Puerto Rico), government and military facilities, and numerous foreign countries. All current software versions of the device are impacted. The product is an automated hematology analyzer used in clinical laboratories for in vitro diagnostic testing of whole blood, pre-diluted whole blood, and body fluids.

Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to address the software defect and ensure accurate patient results.

The recalled product

Product
UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s g
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Hematology Analyzer
Hazard
Affected units
341

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 current software versions are impacted

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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