A customer in (b)(6) reported an occurrence of their thinprep 5000 instrument taking too much fluid out of the vials and loosing quite a bit of fluid between the vial and the slide, and there is not enough cells on the cell spot.They have had to recall pts for sampling.Hologic field service engineer (fse) was dispatched.Hologic field service engineer confirmed and was able to reproduce the error.While servicing the instrument the fse found the rotary vane pump to be the most likely cause of the error.Fse replaced pump to resolve the error.Processed samples to confirm operation.Instrument operations.Hs: this is a reportable event since the thin prep 5000 processor did not perform as intended and the pt needed to be recalled for additional sample collection, which resulted in a delay in pt diagnosis.(b)(6): per the current version of the (b)(6) guidelines, we would not classify this as a reportable event in the eu.There was no injury or misdiagnosis.The reported issue was determined to be a technical nature issue and was successfully reproduced and resolved following field service engineer intervention.
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