Alerta De Seguridad para Synchron Systems Salicylate Reagent

Safety alert

2017-06-29

2017-06-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170629a.html

Medical device safety alert: beckman coulter synchron systems salicylate reagent medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its synchron systems salicylate reagent (saly). all lots of saly with reference number 378194 are affected. the manufacturer 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. according to the manufacturer, 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 and 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. information regarding interference with this drug will be added to the saly chemistry information sheet (cis). the cis will be updated on the beckman coulter website's technical documents webpage. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 june 2017.