Radiometer ABL800 FLEX Recalled for Underestimated Creatinine Measurements
Radiometer America Inc. is recalling ABL800 FLEX analyzers because creatinine measurements may be underestimated by up to 28%, potentially affecting patient safety during radiocontrast x-ray investigations.
What this means for you
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 (contrast-induced nephropathy) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Radiometer America Inc. is recalling 1,619 units of the ABL800 FLEX with Crea (models ABL817, ABL827, and ABL837) due to a defect in creatinine measurement accuracy. The recall was initiated after quality assurance studies in Denmark and Sweden demonstrated that creatinine levels could be underestimated by up to 28% compared to COBAS measurements. This underestimation specifically occurs when measurements on the Autocheck 6+ level 1 (AC6+L1) are less than or equal to 230 micro-meters within a specified insert interval.
The hazard involves the potential for incorrect patient assessment, particularly for patients undergoing radiocontrast x-ray investigations. If a patient's kidney function is underestimated due to low creatinine readings, the exposure to radiocontrast agents may induce kidney insufficiency, a condition known as contrast-induced nephropathy. The affected units were distributed across 32 U.S. states and in Canada, Croatia, Finland, and Russia.
Healthcare facilities and customers should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and returned to Radiometer America Inc. for repair or replacement. Users should consult the manufacturer for specific instructions on handling the affected devices.
The recalled product
- Product
- Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845.
- Manufacturer
- Radiometer America Inc
- Affected units
- 1,619
Distribution
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