Reported Feb 13, 2019 · Terminated
Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and…
Radiometer America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer America Inc · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- ProductABL800 FLEX with Crea. The ABL800 with Crea is available
- in the following configurationsABL817, 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
- Lot codes and dates
- Model ABL817 FLEX Serial Numbers754R2180N003 754R1920N003 754R1426N004 754R1468N002 754R1924N005 754R2504N015 754R2180N005
- Model ABL827 FLEX Serial Numbers
170 of 170 codes
754R0700N002754R2190N004754R2442N006754R2272N002754R2272N004754R1129N006754R2348N001754R2348N006754R2435N007754R1661N002754R1661N004754R2311N004754R1003N003754R1003N005754R1422N004754R1434N008754R1099N004754R1099N005754R1907N006754R1909N003754R1909N006754R2296N004754R1172N006754R2425N003754R2425N004754R2370N005754R2370N006754R1559N001754R1559N003754R1009N005754R1009N006754R1009N007754R1010N006754R1010N007754R1011N001754R2460N008754R2460N009754R2023N002754R1011N006754R1013N001754R1870N001754R1986N004754R2150N006754R2151N001754R2162N003754R2162N005754R2442N008754R2443N001754R2443N004754R1863N006754R1333N003754R2443N002754R2443N003754R1468N003754R1468N004754R2124N006754R0832N007R754R2196N007754R1204N003754R1462N008
- Model ABL837 FLEX Serial Numbers
87 of 87 codes
754R0700N001754R1267N008754R2140N004754R2147N004754R1798N002754R1301N006754R1314N006754R1011N002754R1204N008754R1413N008754R1596N001754R1777N005754R1909N005754R1909N008754R1797N008754R1798N001754R2371N001754R2371N003754R2371N005754R2408N007754R2408N009754R0796N007754R1267N004754R1267N009754R0834N003754R0897N005754R0897N008754R2460N005754R1968N003754R1704N008754R1723N005754R0555N007754R1725N001754R1725N003754R1644N002754R1644N007754R1595N001754R1600N003754R0382N001754R1964N003754R0631N006U754R0853N004754R0896N005754R1010N002754R1010N003754R1050N008754R1051N002754R1172N007754R1173N006754R1469N002754R1831N005754R1831N006754R1948N006754R1953N004754R2223N002754R2223N003754R2429N008754R2473N002754R2473N004754R2473N006
- Amount recalled
- 1619
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Radiometer America Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.