BECKMAN COULTER INC
UNICEL DXC 600 · Chemistry
510(k) Clearances (2)
Substantially Equivalent
Substantially Equivalent
Recalls (10)
Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results.
Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.
Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Bar
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 Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.
The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.
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.
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.
Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results.
It was confirmed that the ORDAC (Over Range Detection And Correction) feature (auto & manual) does not perform correctly for the glucose cup chemistry (GLUCm) when sample type of 'Other' is selected w/operating software versions 1.0 & 1.2. Results for these samples could be elevated as much as twice the actual value. The ORDAC feature does function properly w/serum, plasma, urine & CSF.
MAUDE Adverse Events (10)
FDA Classification (67)
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