translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Recall / Field Safety Notice

mdprc 156 07 18 001

2018-10-21

Saudi Arabia

SFDA

https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13363

The purpose of this communication is to inform you of an issue with the products indicated in table 1 above and provide instructions on actions for your laboratory to take. siemens healthcare diagnostics has identified a bias with advia centaur ckmb calibrator kit lots ending in 64 (ck64) when compared to internal standards and previously released advia centaur ckmb calibrator kit lots ending in 63 (ck63) on the advia centaur/xp/xpt and advia centaur cp systems. the patient sample bias observed when comparing advia centaur ckmb calibrator kit lots ending in 64 to unaffected advia centaur ckmb calibrator kit lots ending in 63 is found in table 2, figure 1 and figure 2. alignment to the internal standardization is restored with the release of advia centaur ckmb calibrator kit lots ending in 68 (ck68). customers may observe a shift in quality control (qc) material, master curve material (mcm) and patient results when transitioning from advia centaur ckmb calibrator lots ending in 64. refer to the additional information section for information related to patient sample bias and bio-rad controls. siemens has also identified the potential for out of range advia centaur ckmb master curve material results when using the lot identified in table 1 on the advia centaur/xp/xpt and advia centaur cp systems. the root cause is currently under investigation.