ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00758-1

Class II

2016-06-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00758-1

Previously unknown drug interferences from sulfasalazine and sulfapyridine have been identified. there is a possibility that drug interference's from administration of sulfasalazine to patients may generate false low alt results and false low glucose-stat results. sulfapyridine may generate false high glucose-stat results (osr6x40).Interference seen with 300mg/l sulfasalazine showed a negative bias of up to 35% for the low alt control and up to 29% for the high alt control.Interference seen with 300mg/l sulfasalazine showed a negative bias of up to 25% (or 1.3 mmol/l) for the low glucose-stat control and up to 13% (or 1.6mmol/l) for the high glucose-stat control.Interference seen with 300mg/l sulfapyridine showed a positive bias of up to 21% (or 1.1 mmol/l )for the low glucose-stat control and up to 9% or (1.1mmol/l) for the high glucose-stat control.There is no risk to patients however there is the potential for a delay in results.

Beckman Coulter is advising users that the IFU has been updated to include additional warnings in the 'Interfering Substances' section. No retrospective review of results is recommended.