ABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results
Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.
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: This Class II medical device recall addresses a functional defect that could cause blood gas analyzers to report inaccurate pH results, potentially affecting clinical decision-making. Although no illnesses or injuries have been reported and the hazard is theoretical (bacterial contamination of calibration solution potentially leading to incorrect readings), this is classified as a risk-of-harm product where the functional accuracy of critical laboratory tests is compromised.
Plain-English summary
The ABL800 FLEX blood gas analyzer (Radiometer Medical ApS, models 393-800 and 393-801) is the subject of a recall affecting approximately 27,127 units distributed worldwide, including throughout the United States. These analyzers perform in vitro testing of blood samples and other specimens to measure pH, blood gases, electrolytes, glucose, and other parameters essential for patient care.
The recall was initiated because calibration solution pH may decrease during the in-use period, potentially due to bacterial growth in calibration solution bottles. This could cause the analyzer to report biased, out-of-specification pH results on blood samples, potentially affecting clinical interpretation.
The recall applies to healthcare facilities, laboratories, and clinical institutions worldwide, including those throughout the United States, that operate the affected analyzer models. Specific units are identified by model number, part number, and UDI(-DI) codes available in the FDA recall documentation.
Healthcare facilities using these analyzers should contact Radiometer Medical ApS for guidance on corrective actions. No illnesses or injuries related to this issue have been reported.
The recalled product
- Product
- ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " 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…
- Manufacturer
- Radiometer Medical ApS
- Affected units
- 27,127
Distribution
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