Recall Z-0801-2019 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
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.
| Date | Jul 2, 2018 |
| Status | Terminated |
| Reason | 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 i |
| Root cause | 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 val |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051968 | ABL8X7 FLEX Radiometer Medical Aps, Oct 16, 2006 |