Gbo complaint no: (b)(4).Received 1rk 454008p/b16063fs for evaluation.We have no further inventory of the material/batch.Samples were tested, with regards to correct assembly, level mark, filling level, draw volume and additive content.Tubes were verified to be correctly assembled and had the correct fill guide line position.Greiner fill mark provides a visual control opportunity for the phlebotomist and for the lab personnel to check for proper volume collection of specimen.Additive content was found to be within specification in all tested samples.Samples were checked for potassium content and none could be detected.Samples have been evaluated in a blood draw.Gel barriers formed correctly and good separation was observed in all tested samples when centrifuging using recommended parameters within 2 hours.The appearance of the gel barriers (minor rbcs within) is similar to those in previous blood draws.No hemolysis as described by the customer was observed.No rbcs in plasma as described by the customer were observed.No customer pictures were provided for comparison.No deviations could be observed on the samples.The complaint cannot be confirmed.
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Customer states: "elevated potassium/repeat's are normal/after centrifuging at times the plasma has a reddish color and the blood appears to seep through the gel.It has been reported from our processing lab rbc are present in the plasma".Tubes are: upright during 30 min clot time; spun within 2 hrs; sometimes showing hemolysis; not uderfilled.Centrifuge is horizon, fixed angle, spins at 3200 rpm for 10 minutes.Additional clarification: initial elevated potassiums are above their range; and the repeats are off of a separate specimen (patient comes back in for redraw) and results are normal.
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