AMH Gen II ELISA Kit. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2013-RN-00613-1

Class II

2013-06-19

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00613-1

This is a follow up to the urgent recall for product correction (tga reference: rc-2012-rn-01227-1) issued in december 2012. beckman coulter has confirmed that undiluted patient samples measured with the amh gen ii elisa kit may generate results that are lower than expected, due to interference from complement. the previous communication indicated that diluted test results may exceed their true value and that using undiluted samples did not impact test results.

Beckman Coulter is asking users to discontinue use of all product with lot numbers less than or equal to 326119. It is recommended that all previous test results are evaluated that were not consistent with the patient's clinical presentation. Beckman Coulter are recommending that clinicians are notified of potential erroneous results at the discretion of the Laboratory Director. Update: Beckman Coulter has provided their customer's with updated package insert and instructions to eliminate the complement interference. The updated information includes steps to be taken to determine if the interference issue affects the product and an updated IFU to follow should the assay kit be affected.