Agency classClass IIOur severity:High FDA (Devices)·Z-2467-2020·Announced 2020-07-08

Radiometer ABL80-FLEX Box Label Recall for Barcode Misinterpretation Risk

Radiometer Medical ApS is recalling ABL80-FLEX box labels because barcode misinterpretation on analyzers may cause patient mix-ups or delayed treatment.

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 device) where injury has not yet been reported, fitting the High severity criteria for potential patient mix-ups or delayed treatment.

Plain-English summary

Radiometer Medical ApS is recalling 9,373 units of ABL80-FLEX-393-839 Box Labels (REF 393-839). These labels are intended for use in laboratory, near patient, or point-of-care settings. The recall covers all lots and includes worldwide distribution, as well as US nationwide distribution across all 50 states, DC, and Canada.

The recall is due to a risk that barcode readers on ALB900 and ABL800 analyzers may misinterpret the contents of some barcode types that do not use a check digit for patient ID or accession number. This misinterpretation may result in patient mix-ups and/or delayed medical treatment. The analyzers are used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit, and oximetry.

Healthcare facilities and laboratories should stop using the affected box labels and contact Radiometer Medical ApS for further instructions. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product: ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - 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 — In Vitro Diagnostics
Hazard: mis-labeling
patient-mix-up
delayed-treatment
Affected units: 9,373

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 lots

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 →

Same manufacturer · Radiometer Medical ApS

See all →

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Radiometer AQURE Software Recall Due to Patient Mix-up Risk
FDA (Devices) · 2023-04-26
High
ABL800 Flex Analyzer Recalled for Potential Measurement Bias
FDA (Devices) · 2022-07-13
High
Radiometer Arterial Blood Sampler recalled due to sterility guarantee loss
FDA (Devices) · 2022-05-25

Same hazard · mis labeling