Retiro De Equipo (Recall) de Innovance D-Dimer assay run on Sysmex CS Systems. An in vitro diagnostic medical device (IVD).

Recall

RC-2017-RN-00112-1

Class II

2017-01-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00112-1

Siemens healthcare diagnostics has confirmed that under very rare circumstances a false negative result may be reportable. the issue may only occur under the following conditions:- the initial result is falsely flagged with an antigen excess error that triggers an automatic reanalysis in a 1/19 dilution; and- the raw signal that is generated from the reanalysis is below the limit of blank (lob) of the method.Under such conditions the low reanalysis raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low optical raw value. this raw value is corrected by the dilution factor and can then be incorrectly calculated from the calibration curve as a falsely low result.

Siemens is advising customers that the threshold for “Min Range” of the extrapolation needs to be changed within the Innovance D-Dimer assay setting on the Sysmex system as follows: - In the CS software, Select “Menu” - Select “Settings” - Select “Assay Group Settings” - Select “Innovance D-dimer” assay - Double click assay parameter “INN DDi” - Under the “Calculation Method” tab, change the current “Extrapolation” threshold for the “Min” extrapolation range from 0.01 to the new threshold of 1.00 - Select “Save” and restart CS-System software After the restart, the system will work with the new setting. Siemens is also recommending that laboratories discuss the customer letter with their Medical Director and consider the need for a look-back of previously generated results that may be affected by this issue.