Complaint (b)(4).Received 50pc 454209/b180435m for evaluation.Received customer pictures.The actual sample (seen in customer pictures) was not received.We have no further inventory of the material/batch.A check of quality, production and maintenance records shows no deviations related to the reported issue.Samples were tested, according to gbo standard testing procedures, with regards to correct assembly, level mark, filling level, draw volume according to iso 6710 'single use containers for venous blood specimen collection' and clsi gp39-a6 regulations for 'evacuated tubes and additives for blood specimen collection'.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.Both standards specify the draw volume to be within +/- 10% range of the nominal fill volume.No visual deviation in fill volume, sporadic low or high fill, could be observed in the tested samples.All tubes tested filled within the +/-10% tolerance range.No short fills could be observed on the samples.No deviations with the cap assembly could be observed prior to, during or after filling of the tubes.All components (cap bodies, rubber stoppers and ring plates) were intact and remained intact.The complaint could not be confirmed.
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