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Radiometer America Inc recalls Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and AB

Recalled February 13, 2019 · FDA recall Z-0801-2019 · Radiometer America

Hazard
From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine. · FDA Class II
Units
1619
Sold at
US: AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WA, WI, and WV OUS: Canada, Croatia, Finland and Russia

Description

From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine.

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(s)
Radiometer America Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Radiometer America Inc recalls Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and AB | RecallWatchUSA