Radiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch
Radiometer America Inc is recalling 2,131 ABL800 analyzers because software may cause a mismatch between patient demographics and test results.
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 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (patient data mismatch) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Radiometer America Inc is recalling 2,131 ABL800 analyzers, including model numbers 393-800 and 393-801. The recall covers all serial numbers for specific configurations, including the ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, ABL835, ABL817, ABL827, and ABL837.
The recall is being conducted because the analyzer software may cause a mismatch of patient demographics and test results when a certain sequence of events occurs. This issue could lead to incorrect patient records or clinical decisions based on mismatched data.
The affected analyzers were distributed nationwide, to military and government entities, and to Canada. Users should contact Radiometer America Inc for further instructions on how to address the software issue.
The recalled product
- Product
- ABL800 analyzer, model numbers 393-800 and 393-801.
- Manufacturer
- Radiometer America Inc
- Affected units
- 2,131
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 (8)
- ABL805
- ABL810
- ABL815
- ABL820
- ABL825
- ABL830
- ABL827
- and ABL837.
Distribution
Distributed nationwide across the United States.
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