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.
Recall
- Recall Number
- Z-0801-2019
- Event Number
- 81490
- Firm
- Radiometer America Inc
- FEI Number
- 3010420736
- Product Code
- CHL
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- July 2, 2018
- Terminated
- April 2, 2024
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232
Description
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.
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.
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
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