The cause of the out of range qc results is return of contamination of an instrument which had previously had chemistry wash lot rd41041 on the instrument.A decontamination of the instrument had occurred after removal of lot rd41041 and decontamination but contamination returned.Siemens has confirmed bacterial contamination in chemistry wash lot rd41041.A positive bias will be observed on ctni, ltni, tsh, pbnp and lpbn and a negative bias will be seen on ft4 when this lot is first placed on the instrument without recalibration of methods.Recalibration of these assays when using this lot will not correct the problem and may cause falsely high or low results.Siemens issued an urgent medical device recall letter dated (b)(4) 2014, communication # (b)(4), to all accounts who had received the impacted lot.Subsequently, siemens issued an urgent medical device recall update dated (b)(4) 2014, communication #(b)(4), to all accounts who had received the impacted lot.Customers were advised of the immediate remedial actions to be taken by the customer who had previously had lot rd41041 on their system: if available, move ctni, ltni, pbnp, lpbn, tsh, and ft4 testing to an alternate instrument, either a dimension system which was not exposed to chemistry wash lot rd41041 or an instrument with an alternate methodology or platform.If the above action is not possible, patient samples must be bracketed with low level qc for all affected assays.Before reporting patient results, qc values processed before and after the patient sample(s) must be within acceptable qc limits.If any qc values are not acceptable, do not report the patient result(s) and contact siemens for direction on further actions.The update stated that siemens would contact customers with details to schedule remedial actions to prevent further contamination of their dimension system.
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