Radiometer ABL800 Analyzer Recalled for Barcode Misinterpretation
Radiometer America Inc. is recalling 1,749 ABL800 analyzers because a barcode scanner error may display results from a different patient.
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 involves a risk-of-harm product (medical device) where a software/hardware defect could lead to incorrect patient data, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Radiometer America Inc. is recalling 1,749 ABL800 analyzers with the FLEXQ module. These devices are intended for in vitro testing of whole blood, expired air, and pleura samples to measure various parameters including pH, electrolytes, and co-oximetry values.
The recall is due to a defect where the analyzer's scanner may misinterpret the barcode on a registration receipt. When this occurs, the analyzer may print or display a result belonging to a different patient rather than the current sample. This error could lead to incorrect clinical decisions based on mismatched data.
The affected units were distributed nationwide in the United States and internationally to Canada. Users of these devices should contact Radiometer America Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- 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…
- Manufacturer
- Radiometer America Inc
- Affected units
- 1,749
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 (1)
- All serial numbers
Distribution
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