Retiro De Equipo (Recall) de cobas e 411 analyser. An in vitro diagnostic medical device (IVD)

Recall

RC-2017-RN-00847-1

Class II

2017-07-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00847-1

Roche diagnostics have identified that in very rare cases, a software malfunction in the “sample & control” data file may occur, which could lead to a potential sample mismatch (incorrect test order and incorrect result reporting). the impact of any data mismatch cannot be predicted. the system may still be used routinely as long as the workaround and corrective actions are taken into account. this software malfunction can only occur:- when the “sample data clear” function is not performed routinely as indicated in the operator’s manual; and- when the “sample & control” datafile of the cobas e 411 analyser is filled with = 2,000 records.All tests run on the cobas e 411 analyser are potentially affected if these criteria are met. the extent of the bias cannot be predicted and the detectability of this issue is not certain. a relevant medical risk cannot be entirely excluded.A small number of complaints have been received, however none from australian customers, to date.

Roche Diagnostics is requesting that customers adhere to the following: 1. Until the software update has been installed, it is MANDATORY to perform a “Sample Data Clear” daily: “Sample Data Clear” is step no. 2 in the Work Flow Guide in the System Overview window. Please note: A Sample Data Clear deletes all sample records and moves QC data to the QC view. It is recommended to perform the backup procedure on a regular basis, depending on the data volume at the laboratory site. If the system is connected to a host, ensure that all data has been uploaded before performing a sample data clear. 2. Follow the instructions given in the customer letter supplied and then display it in a prominent place in the laboratory until the mandatory software upgrade has been installed.