Radiometer recalls ABL800 FLEX with Crea models (ABL817, ABL827, ABL837) due to potential underestimation of creatinine levels, which may lead to kidney issues in patients undergoing radiocontrast x-rays.
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.
Radiometer is recalling specific ABL800 FLEX with Crea models because they might show lower creatinine levels than actual, which could cause kidney problems in patients needing radiocontrast x-rays. This is based on studies in Denmark and Sweden.
The analyzer may show creatinine levels up to 28% lower than actual values in certain conditions. This underestimation could lead to patients receiving radiocontrast agents when their kidneys are already compromised, potentially causing kidney failure.
Patients undergoing radiocontrast x-rays who use these specific blood analyzers may be at risk of kidney issues if the creatinine levels are underestimated. The risk is tied to the patient's health condition and the use of radiocontrast agents.
Check if your device is an ABL800 FLEX with Crea model (ABL817, ABL827, or ABL837) with the listed serial numbers. The product is sold under the brand Radiometer America Inc.
Identify if your device is an ABL800 FLEX with Crea model (ABL817, ABL827, or ABL837) using the serial numbers listed in the recall.
The recall is due to studies showing that these analyzers may underestimate creatinine levels by up to 28% in specific conditions, which could lead to kidney issues in patients undergoing radiocontrast x-rays.
If you use this device for blood tests and your patient is undergoing radiocontrast x-rays, there is a risk of kidney problems if the creatinine levels are underestimated.
Check if your device is listed in the recall by comparing the serial numbers provided. If it is, you may need to contact Radiometer for further instructions.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-0801-2019 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-0801-2019 from Radiometer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
