Complaint (b)(4).Received 37 tubes 454428/b171235a for evaluation.Received customer data.We have no further inventory of the material/batch.The complaint is confirmed.We have already performed an investigation and recommend the use of lithium heparin tubes for ammonia analysis.Edta tubes according to greiner ifu are for routine immunohematology testing, rh typing and antibody testing, viral marker testing, and testing plasma in molecular diagnostics.
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Customer states that ammonia results, during a product verification study, were biased high when compared to the control tubes (bd).The study was done with staff volunteers, five volunteers per each study.Once collected, specimens were refrigerated until all volunteers were drawn.Customer estimated 20 minutes for collection of all volunteers.Specimens were centrifuged at 4000rcf for 3 minutes using statspin.After centrifugation, specimens were immediately aliquoted into "tea" (analyzer) cups and placed on the instrument.Customer did not randomize the draws per study, however specimens were drawn first in the bd tubes and first in the greiner tubes in the first and second studies respectively.Customer ran the ammonia on roche c502.Customer advised they follow the assay package insert.
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