Radiometer ABL800 Software Recall for HL7 Data Transmission Errors
Radiometer America is recalling ABL800 software version 6.12 because HL7 2.5 configuration errors may cause queued blood test results to be mixed up when transmitted to hospital systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves data integrity errors (mixed-up results) rather than direct physical injury or death, fitting the criteria for moderate severity involving significant but non-immediate physical harm risks.
Plain-English summary
Radiometer America Inc is recalling ABL software version 6.12 for the ABL800 analyzer. The recall involves 11,929 ABL 8xx units distributed worldwide, including across the United States and numerous international countries. The analyzers are intended for in vitro testing of whole blood, expired air, and pleura samples for various parameters such as pH, pO2, pCO2, and electrolytes.
The recall was initiated after a customer reported an error on an ABL8xx instrument configured to a Hospital Information System (HIS) using the HL7 version 2.5 data transfer protocol. If the connection between the instrument and the HIS is broken, results are queued for later transmission. When the ABL and HIS are configured with HL7 2.5, any results in the queue may be mixed up when the instrument transmits them.
Healthcare facilities using the affected software should contact Radiometer America Inc for instructions on correcting the configuration or updating the software to prevent data transmission errors.
The recalled product
- Product
- 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…
- Manufacturer
- Radiometer America Inc
Distribution
Part of a larger recall action
This product is one of 3 recalled by Radiometer America Inc 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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