FDA Device recall Z-0801-2019
Product: ABL800 FLEX with Crea
- FDA Device
- Class II
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of Product: ABL800 FLEX with Crea by Radiometer America, citing from three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0801-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-02 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Radiometer America |
| Distribution | 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, WV |
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.
Reason
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.
Identifiers
| code_info | Model ABL817 FLEX Serial Numbers: 754R2180N003 754R1920N003 754R1426N004 754R1468N002 754R1924N005 754R2504N015…Model ABL817 FLEX Serial Numbers: 754R2180N003 754R1920N003 754R1426N004 754R1468N002 754R1924N005 754R2504N015 754R2180N005 Model ABL827 FLEX Serial Numbers: 754R0700N002 754R2190N004 754R2442N006 754R2272N002 754R2272N004 754R1129N006 754R2348N001 754R2348N006 754R2435N007 754R1661N002 754R1661N004 754R2311N004 754R1003N003 754R1003N005 754R1422N004 754R1434N008 754R1099N004 754R1099N005 754R1907N006 754R1909N003 754R1909N006 754R2296N004 754R1172N006 754R2425N003 754R2425N004 754R2370N005 754R2370N006 754R1559N001 754R1559N003 754R1009N005 754R1009N006 754R1009N007 754R1010N006 754R1010N007 754R1011N001 754R2460N008 754R2460N009 754R2023N002 754R1011N006 754R1013N001 754R1870N001 754R1986N004 754R2150N006 754R2151N001 754R2162N003 754R2162N005 754R2442N008 754R2443N001 754R2443N004 754R1863N006 754R1333N003 754R2443N002 754R2443N003 754R1468N003 754R1468N004 754R2124N006 754R0832N007R 754R2196N007 754R1204N003 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0801-2019%22
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