The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3114-2017·Announced 2017-09-13

Beckman Coulter HmX Analyzers Recalled for Potential Blast Detection Failure

Beckman Coulter is recalling HmX CP and HmX AL analyzers because they may fail to flag or detect blasts in rare blood sample situations.

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 3/5 (High).

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 diagnostic device) where the failure to detect blasts could lead to misdiagnosis, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Beckman Coulter Inc. is recalling the Coulter HmX CP and Coulter HmX AL Analyzers. The recall involves 3,326 units distributed worldwide, including the United States and numerous international locations. The affected products include specific catalog numbers for the HMX CP and HmX AutoLoader, across all software versions.

The recall was initiated because Beckman Coulter determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the HmX Analyzers may not flag or detect blasts in some blood samples. The purpose of the HmX Hematology Analyzer is to separate normal patients from those who need additional studies to diagnose abnormalities.

Healthcare facilities and laboratories using these analyzers should contact Beckman Coulter for further instructions on how to manage the recall and ensure patient safety.

The recalled product

Product
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell…
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Hematology Analyzer
Hazard
Affected units
3,326

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 (9)

  • Catalog Number(s): HMX CP - 178832
  • 178833
  • 178834
  • A91062
  • A90994
  • HmX AutoLoader - 6605522
  • 6605523
  • 6605524
  • All software versions.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states 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 →

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