The Recall Desk
HighFDA (Devices)·Z-1760-2020·Announced 2020-04-29

Radiometer ABL90 FLEX Analyzer Recalled for Barcode Reader Error

Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with software below 3.4MR2 because the barcode reader may misinterpret labels, risking patient mixups and delayed treatment.

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 where the malfunction could lead to delayed medical treatment, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Radiometer Medical ApS is recalling 12,822 units of the ABL90 FLEX Analyzer, Model Numbers 393-090, equipped with software versions below 3.4MR2. The device is intended for use in laboratory, near-patient, or point-of-care settings. The recall covers units distributed worldwide, including across the United States and numerous international locations.

The recall was initiated after the firm received reports that the analyzer's barcode reader misinterpreted the contents of locally printed barcode labels used to enter patient IDs or accession numbers. This malfunction could result in patient mixups or the loss of samples, which may lead to delayed medical treatment.

Healthcare facilities and laboratories using these devices should verify their software versions and contact Radiometer Medical ApS for instructions on updating the software or replacing affected units. Users should not rely on the barcode reader for patient identification until the issue is resolved.

The recalled product

Product
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Manufacturer
Radiometer Medical ApS
Category
Medical Device — Laboratory Analyzer
Hazard
Affected units
12,822

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)

  • software versions below 3.4 MR2

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Radiometer Medical ApS 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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