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-00211-1

Class II

2016-02-26

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00211-1

Siemens has determined that affected lots of dimension vista blood urea nitrogen (bun) may exhibit inaccurate patient and/or qc results. the issue has been isolated to flex reagent cartridges manufactured from specific mold cavities. investigations indicate a loss of activity of the gldh reagent wells from specific mold/cavity identifiers. not all flexes are affected.·if calibration is performed using an unaffected well and patient results are subsequently run using an affected well, bun results may be falsely depressed by up to approximately 50% across the concentration range tested of 3.9 – 280 mmol/l (11–784 mg/dl). · if calibration is performed using an affected well, bun results may be falsely elevated by up to approximately 64% across the concentration range tested of 5.4 – 264 mmol/l (15–740 mg/dl)the risk to health as a result of this issue is remote and limited to falsely depressed bun results which may potentially result in the delay in the follow-up for kidney disease.

Siemens is advising users to inspect the affect products to determine if the cartridges have the affected Cavity Number, and discard any cartridges that have the specific lot and cavity number combinations. Cartridges which do not have the affected cavity numbers are unaffected and can continue to be used. Siemens is not recommending a review of previously generated results, however please discuss this letter with your Medical Director and consider the need for a look back at patient results generated with the affected cartridges.