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.
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 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
- 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
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.
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