AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM) 의 리콜

Recall

RC-2017-RN-00349-1

Class II

2017-03-14

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00349-1

In september 2014, siemens healthcare diagnostics issued customer notification dc 14-09 that addressed a high rate of “abnormal assay” test report messages for its dimension ammonia (amm) assay. internal testing revealed that the “result monitor below” mean factor for ammonia (ammdf119) is set with a narrow limit, which may cause some ammonia results to be inappropriately flagged with an “abnormal assay”. flagged amm “abnormal assay” results may be attributed to a contamination of open wells of the amm flex reagent cartridge. quality control (qc) and patient samples may be affected; however, affected results are appropriately flagged.

Siemens is reducing the AMM open well stability from 3 days to 1 day (24 hours) and providing instructions for managing this change. Dimension AMM IFU revision E will reflect this change. The new version of Dimension software, 10.2, will do the following: - Automatically move to a new well every day. This decrease in the open well maximum duration reduces the amount of time the AMM reagent is exposed to any potential contaminates, reduces the need for customers to manually move to a new reagent well, and aids in the prevention of erroneous flagging. - Contain the Below Mean Factor limit of 0.90. Users are notified that until Dimension 10.2 software is installed on their instruments, manually move to a fresh AMM well of reagent every day. Also, to reduce the likelihood of false AMM “Abnormal assay” messages, verify that the Below Mean Factor for the Result Monitor is set to the revised limit of 0.90 by following instructions provided in the customer letter.