Retiro De Equipo (Recall) de Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). An in vitro diagnostic medical device (IVD)

Recall

RC-2016-RN-00757-1

Class II

2016-06-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00757-1

In february 2016, siemens healthcare diagnostics issued a letter, informing customers of well-to-well accuracy shifts for specific lots of dimension vista bun causing inaccurate patient and/or quality control results. preliminary investigation demonstrated loss of enzymatic activity of the gldh reagent wells made from a specific mold/cavity. siemens have since confirmed there is an additional cause of reduced gldh activity. · if calibration is performed using an unaffected well and samples are tested using an affected well, bun results may be falsely depressed by up to approximately 50% across the concentration range of 11 – 784 mg/dl. qc will detect the issue.· if calibration is performed using an affected well and samples are subsequently tested using an unaffected well, bun results may be falsely elevated by up to approximately 64% across the concentration range of 15 – 740 mg/dl. there may be in the delay in the follow-up for kidney disease.

Siemens is providing work around instructions to users to follow in order to detect the affected reagent well sets. The actions are strongly recommended to minimise the usage of affected reagents wells. Additionally, users are advised to discard any reagent cartridges with cavity number B4. Siemens is not recommending a review of previously generated results however, a review due to this issue is at the discretion of the laboratory director. This action has been closed-out on 20/01/2017.