IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Bias 의 리콜

Recall

RC-2015-RN-00131-1

Class II

2015-02-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00131-1

Siemens healthcare diagnostics has confirmed a positive bias with the bio-rad lyphochek tumor marker plus control and the bio-rad liquichek tumor marker control when used with immulite 2000/immulite 2000 xpi gi-ma (ca 19-9) assay kit lots 312 and 313.The bias in quality control values is the result of the introduction of a new lot of the bead coat antibody (murine monoclonal anti-ca 19-9 antibody) in kit lot 312. when comparing kit lot 312 with kit lot 311, siemens observed an average percent bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 u/ml and an average percent bias of 5% (ranging from 1% to 11%) for patient samples recovering from 540 to 660 u/ml.Future kit lots are expected to recover quality control and patient samples similar to kit lot 312.

Siemens is advising that patients may need to be re-base lined with kit lot 312 or higher. A look back over previously generated results should be discussed with the treating physician.