Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The ABL software version 6.12 for the ABL800 analyzer. The Recalled by Radiometer America Inc Due to A customer has reported an error on an...
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
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, 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) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, 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) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
Quantity: 11929 ABL 8xx units
Why Was This Recalled?
A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t
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