BECKMAN COULTER INC
UNICEL DXC 600I · Chemistry
510(k) Clearances (1)
Substantially Equivalent
Recalls (10)
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system.
Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.
This recall was initiated because Beckman Coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of missing or incorrect assay reagents. In these cases both false positive and false negative results are possible, depending upon the assay configuration.
The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples. The Impact: (1) Neonatal samples drawn by lancets are more likely to be hemolysed to a degree sufficient to cause interference with glucose estimation and are a special at-risk population, (2) Other hemolysed samples may be similar
Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results.
The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering.
Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.
MAUDE Adverse Events (10)
FDA Classification (67)
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry