Product: ABL800 FLEX with Crea — Class II medical device recall Z-0801-2019
Terminated recall by Radiometer America Inc, reported 2019-02-13, distributed in AZ, CA, CO, CT, FL, GA, IA, ID…. From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for qualit
| Recall number | Z-0801-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Brea, CA, United States |
| Recall initiated | 2018-07-02 |
| Classified | 2019-02-05 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2024-04-02 |
| Distributed | 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 |
| Countries outside the US | CA, FI, HR, RU |
| Quantity | 1,619 |
| Serial numbers | 754R0079N007, 754R0382N001, 754R0512N008, 754R0555N007, 754R0574N001, 754R0574N002, 754R0574N004, 754R0579N001, 754R0581N005, 754R0606N004, 754R0631N006U, 754R0700N001, 754R0700N002, 754R0765N007, 754R0796N007, 754R0832N007R, 754R0834N003, 754R0853N004, 754R0896N005, 754R0897N005, 754R0897N008, 754R1001N004, 754R1003N003, 754R1003N005, 754R1009N005 and 239 more |
| Model numbers | 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845, ABL817, ABL827, ABL837 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0801-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.