The Recall Desk
HighFDA (Devices)·Z-1383-2019·Announced 2019-05-29

Beckman Coulter Recalls UniCel DxH 600 Hematology Analyzers for Platelet Errors

Beckman Coulter is recalling 2,059 UniCel DxH 600 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 risk-of-harm product (medical device) where a diagnostic error could lead to unrecognized thrombocytopenia, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Beckman Coulter Inc. is recalling 2,059 UniCel DxH 600 Coulter Cellular Analysis Systems (REF number B23858). 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 benchtop hematology analyzers used for in vitro diagnostic testing of whole blood, pre-diluted whole blood, and body fluids. The recall covers all current software versions of the instrument. The devices were distributed worldwide, including US nationwide (including Puerto Rico), government and military facilities, and numerous foreign countries.

Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to address the issue. The source text does not specify a specific action for consumers, as these are professional medical devices.

The recalled product

Product
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilitie
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Hematology Analyzer
Hazard
Affected units
2,059

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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