Agency classClass IIOur severity:High FDA (Devices)·Z-2468-2020·Announced 2020-07-08

Radiometer ABL80-FLEX CO-OX Box Label Recall for Barcode Misinterpretation

Radiometer Medical ApS is recalling ABL80-FLEX CO-OX 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 where injury has not yet been reported, specifically the potential for patient mix-ups and delayed medical treatment due to barcode misinterpretation.

Plain-English summary

Radiometer Medical ApS is recalling 1,981 units of ABL80-FLEX CO-OX 393-841 Box Labels (REF 393-841). The recall covers all lots and includes worldwide distribution, with 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 product is intended for use in a laboratory environment, near patient, or point-of-care setting. Users should stop using the affected labels and contact the manufacturer for further instructions.

The recalled product

Product: ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - 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
Affected units: 1,981

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

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Same hazard · mis labeling