Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ABL90 FLEX Analyzer Recalled by Radiometer Medical ApS Due to The firm received reports of occurrences where the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Radiometer Medical ApS directly.
Affected Products
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.
Quantity: 12,822 units
Why Was This Recalled?
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Radiometer Medical ApS
Radiometer Medical ApS has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report