The instrument produced the message h&h check failed. While the exact root cause cannot be determined from this data analysis, failures like this can be detected by h&h check. However, it is found that the rbc and plt are lower for the run on the unit at05050 and other parameters are okay in comparison to the run on unit at05051. The data does not reveal any abnormality that may contribute to the failure. Raw data was provided and analysis revealed the following: the raw count and the histogram information were reviewed carefully. The unit is currently performing within qc specifications with respect to controls and reproducibility recent 6c control data submitted for dxh at05050 showed that this instrument recovered low hgb values outside of the expected range on level 1 on the day after the event, (b)(6) 2011. The controls were run before and after the event and results were within expected ranges on the day of the event. Specimens analyzed before and after this specimen were not affected.
#Beckman coulter dxh manual#
The customer stated that the specimen was not a cold agglutinin, lipemic, icteric, or hemolyzed and no manual manipulation of the specimen was done. Please contact your Beckman Coulter sales representative or distributor for more information. Specimen was drawn in a 5 ml bd vacutainer tube stored at room temperature and analyzed fresh. B23858 - UniCel DxH 600 Coulter Cellular Analysis System This product may not be available in your country or region at this time. The results were investigated due to an h&h check failed definitive message. The instrument generated suspect messages pertained to the wbc differential. The Beckman Coulter UniCel DxH 800 is a hematology analyzer incorporating new electronic and mechanical design with advanced algorithm technology to perform CBC, white blood cell (WBC) differential, nucleated red blood cell (NRBC), and reticulocyte analysis. The erroneous results were not reported outside the laboratory hence, patient treatment was not impacted and no injury or death was reported.Ī further review of the printouts submitted revealed that results for wbc, hgb, plt, and the calculated parameter hct were also erroneously low. No instrument flags were generated on these parameters. The customer reported obtaining, erroneous high mch and mchc, and low rbc result on the unicel dxh 800 coulter cellular analysis system for one patient when compared to the results obtained from an alternate dxh 800.