The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.ĭxI System Software versions: 2.3, 2.4, 4.1, 4.2.1, 4.3 (Current released version), 4.3.2 (Released to a single Japanese customer only) The questioned reagent packs were sent to beckman coulter for further evaluation.Class 2 Device Recall UniCel DxI 800 Access Immunoassay SystemsĪnalyzer chemistry (photometric, discrete), for clinical use - Product Code JJE There has been no report of patient injury or change in patient treatment associated with this event. The customer is uncertain if erroneous patient results were released out of the laboratory due to this event. The fse noted the access vitamin b12 assay packs faulty with lesser concentration of particles.
The fse completed another precision test and noted the sample means across all pipettors correlated. The fse loaded a new reagent pack (from the same lot number 270139) on the instrument, and the customer successfully completed calibration and quality control (qc). The fse also evaluated the dxi 800 instrument questioned in this report (serial number (b)(4)) for the same elevated b12 performance by running two replicates of the s0 calibrator, which yielded results of 170 and 152. Subsequent quality control (qc) was performed and failed.Ī beckman coulter field service engineer (fse) was dispatched to evaluate the laboratory's other dxi 800 instrument questioned and performed multiple hardware repairs, which did not resolve the sporadically elevated b12 qc performance. Pipettor verification was performed and pipettor #2 failed. The customer was advised to perform a precision test on each pipettor and erratic vitamin b12 results were obtained. This issue was initially identified on a separate dxi 800 instrument (serial number (b)(4)) using the same vitamin b12 lot number. This report documents the elevated vitamin b12 qc results obtained on (b)(6) 2013.
The affiliate reported the customer alleged elevated vitamin b12 quality control (qc) results, on separate days ((b)(6) 2013 through (b)(6) 2013), involving the access vitamin b12 assay (lot number 270139) utilized in conjunction with the unicel dxi 800 access immunoassay system (serial number (b)(4)).
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