Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ABL800 analyzer with FLEXQ module. Device intended for in vitro Recalled by Radiometer America Inc Due to Due to misinterpretation of the barcode by 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 America Inc directly.
Affected Products
ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter
Quantity: 1,749 analyzers
Why Was This Recalled?
Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Radiometer America Inc
Radiometer America Inc 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