Siemens healthcare diagnostics has confirmed internally that for a group of affected actin lots including lot 557134, the recovery of controls can be found outside the assigned ranges.Furthermore, a drift in the normal range towards higher results has been observed.This indicates a change of the product performance over the shelf life.Siemens has confirmed a drift greater than 3 seconds in the normal aptt range and / or greater than 15 % in the pathological range over the shelf-life.It is possible that patients with values close to the medical decision points could exhibit a deviation of up to 4 seconds for the normal range and up to 33% for the pathological range.The described drift towards higher aptt values will be recognized in most cases by control recovery out of the assigned range.Siemens issued an urgent medical device recall communication br-01315 dated march 2015 to customers who had ordered the affected lots advising them to discontinue the use of the lots.Siemens offered a no charge replacement with a non-impacted lot.
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