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U.S. Department of Health and Human Services

Class 2 Device Recall ABL800 Flex with Crea

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  Class 2 Device Recall ABL800 Flex with Crea see related information
Date Initiated by Firm July 02, 2018
Create Date February 05, 2019
Recall Status1 Terminated 3 on April 02, 2024
Recall Number Z-0801-2019
Recall Event ID 81490
510(K)Number K051968  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
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.
Code Information 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 754R1462N008 754R2518N006 754R2521N005 754R2521N007 754R2521N011 754R1887N003 754R1887N006 754R1143N006 754R1143N007 754R1679N004 754R1159N001 754R1159N002 754R2363N004 754R2366N004 754R2367N002 754R2369N001 754R2369N002 754R2369N003 754R2058N002 754R2058N004 754R1766N008 754R1767N004 754R1768N001 754R1778N004 754R1778N008 754R1895N003 754R1907N001 754R1667N003 754R1001N004 754R1887N002 754R1864N003 754R1869N007 754R2347N006 754R0765N007 754R1669N006 754R2458N008 754R2458N009 754R2080N004 754R2080N007 754R2080N008 754R2081N001 754R2081N002 754R1829N007 754R1829N008 754R0512N008 754R1682N001 754R2459N013 754R2459N014 754R1220N004 754R1220N005 754R1561N004 754R1781N002 754R1049N005 754R2441N009 754R1148N003 754R1148N004 754R1817N006 754R1818N003 754R1829N003 754R2156N003 754R2156N004 754R2387N001 754R2387N003 754R2387N004 754R2459N015 754R2460N001 754R2475N007 754R2481N005 754R2481N006 754R2486N006 754R2486N007 754R2486N014 754R2489N006 754R2491N009 754R2491N013 754R2503N007 754R2503N008 754R2503N012 754R2504N018 754R2504N020 754R2530N014 754R2530N015 754R1403N007 754R0579N001 754R1759N003 754R2013N005 754R2013N006 754R1984N003 754R1985N002 754R2023N003 754R2412N003 754R2412N006 754R2218N002 754R2024N002 754R2366N003 754R2366N006 754R0574N001 754R0574N002 754R0574N004 754R1875N001 754R1876N007 754R2152N001 754R1404N001 754R1404N002 754R1404N003 754R2321N002 754R2062N010 754R2062N011 754R1682N002 754R2217N003 754R1336N006  Model  ABL837 FLEX Serial Numbers: 754R0700N001 754R1267N008 754R2140N004 754R2147N004 754R1798N002 754R1301N006 754R1314N006 754R1011N002 754R1204N008 754R1413N008 754R1596N001 754R1777N005 754R1909N005 754R1909N008 754R1797N008 754R1798N001 754R2371N001 754R2371N003 754R2371N005 754R2408N007 754R2408N009 754R0796N007 754R1267N004 754R1267N009 754R0834N003 754R0897N005 754R0897N008 754R2460N005 754R1968N003 754R1704N008 754R1723N005 754R0555N007 754R1725N001 754R1725N003 754R1644N002 754R1644N007 754R1595N001 754R1600N003 754R0382N001 754R1964N003 754R0631N006U 754R0853N004 754R0896N005 754R1010N002 754R1010N003 754R1050N008 754R1051N002 754R1172N007 754R1173N006 754R1469N002 754R1831N005 754R1831N006 754R1948N006 754R1953N004 754R2223N002 754R2223N003 754R2429N008 754R2473N002 754R2473N004 754R2473N006 754R2473N007 754R2474N011 754R2474N012 754R2484N004 754R2503N010 754R2503N011 754R2504N009 754R2504N010 754R2504N012 754R2504N014 754R2519N005 754R2519N010 754R2519N011 754R2519N014 754R2100N005 754R1886N009 754R1887N005 754R2058N001 754R2058N005 754R1580N004 754R1580N005 754R1580N007 754R2429N009 754R0581N005 754R0079N007 754R0606N004 754R1051N003 
Recalling Firm/
Manufacturer		 Radiometer America Inc
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact
800-736-0600 Ext. 1
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Under Investigation by firm
Action On 07/06/2018, the firm sent a Priority Level: Recall Letter to customers via Federal Express Courier Service informing them that the firm has recently become aware that the ABL800 FLEX analyzer can potentially report lower than expected cCrea results on patient samples. The difference has been reported to be as high as -28%. The issue may not be caught by running QC, as the QC will be lower, but still within range. Risk for the patient The described error may potentially lead to an underestimation of the actual serum creatinine concentration (cCrea) of up to 28% or erroneous measurement values for cCrea, resulting in no detection of renal insufficiency or underestimation of moderate to severe renal failure. In case of a non-detected minor renal insufficiency, the patient may be subjected to diagnostic imaging procedures involving intravenous injection of contrast, which may, in a worst-case scenario, lead to acute renal failure (contrast-induced nephropathy, CIN). Affected product: All ABL800 FLEX analyzers measuring cCrea. Interim Countermeasure Before reporting cCrea results, verify the performance of the membrane units as described below: -If not already installed, install S7835 Autocheck 6+. Level 1 (#944-094) -Manually adjust the cCrea lower limit for S7835 AutoCheck 6+, level 1 by +20 ¿mol/L (example: Adjust from 210 ¿mol/L to 230 ¿mol/L). You must do this for every lot of QC ampoules used for the verification. -Perform one quality control measurement using S7835 AutoCheck 6+, level 1 on already installed Crea membrane units to verify the cCrea performance. If the QC result is out of range, install new Crea A and Crea B membranes. Until further notice, follow the procedure every 24 hours and upon replacement of Crea A and Crea B membranes: -Perform one quality control measurement using S7835 AutoCheck 6+, level 1, to verify the cCrea performance. -If the QC result is out of range, install new Crea A and Crea B membranes The abov
Quantity in Commerce 1619
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = RADIOMETER MEDICAL APS
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