Synchron Systems Salicylate Reagent. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00844-1

Class II

2017-07-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00844-1

As a result of internal investigations, beckman coulter has identified temozolomide, an oral antineoplastic drug used to treat certain types of brain cancers, as a potential source of interference with synchron salicylate reagent (saly).- temozolomide concentrations of 40 mg/l or greater may cause a negative bias in salicylate test results of up to -22%.- the half-life of temozolomide is approximately 1.8 hours, with the active half-life of the metabolite being slightly longer. the probability of an erroneous patient result will be dependent upon the times of administration and dosages of both drugs, salicylate & temozolomide. longer intervals of time between administration of the drugs and the testing will reduce the probability and severity of harm. lower doses of either drug will also reduce the severity of harm. the worst case scenario only occurs if a patient that is overdosed on salicylates is tested within a short period of time after receiving a high dose of temozolomide.

No immediate action is required by laboratories other than being aware of this issue as the IFU is being updated. Beckman Coulter is not recommending a retrospective review of prior test results.