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.
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 (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
- 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
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 →Related recalls
Same manufacturer · Radiometer Medical ApS
See all →- ModerateRadiometer ABL90 Series Blood Analyzers May Unexpectedly Freeze
FDA (Devices) · 2025-04-30
- HighABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results
FDA (Devices) · 2024-07-31
- HighRadiometer AQURE Software Recall Due to Patient Mix-up Risk
FDA (Devices) · 2023-04-26
- HighABL800 Flex Analyzer Recalled for Potential Measurement Bias
FDA (Devices) · 2022-07-13
- HighRadiometer Arterial Blood Sampler recalled due to sterility guarantee loss
FDA (Devices) · 2022-05-25
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02