Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00839-1

Class II

2017-07-06

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00839-1

Siemens healthcare diagnostics has become aware of sulfasalazine and sulfapyridine drug interference in certain assays which use nadh and/or nadph to generate reduction oxidation reactions which produce colorimetric signals.Siemens has confirmed that falsely depressed or falsely elevated results may occur on samples drawn from patients taking sulfasalazine and sulfapyridine. sulfasalazine is the accepted treatment for inflammatory bowel disease, ulcerative colitis, crohn’s disease, rheumatoid arthritis, inflammatory arthritis, and uveitis. sulfapyridine is used occasionally for dermatitis herpetiformis and related skin disorders when alternative treatment is unsuitable.Due to this drug interference, siemens will update the limitations of the procedure section of the instructions for use (ifu) for specific dimension and dimension vista assays.

Siemens is requesting that Customers: 1. Review this letter with their Medical Director; 2. Venipuncture should occur before drug administration of Sulfasalazine or Sulfapyridine as indicated under Reason/Issue. Baseline assay values before administration of Sulfasalazine or Sulfapyridine therapy would not be affected; 3. If any complaints of illness or adverse events are received associated with the specified products within the Customer Letter immediately contact your local Siemens Customer Care Centre or your local Siemens technical support representative; 4. Complete and return the Response Form by Friday 4th August 2017 as confirmation that you received and understood the bulletin; and 5. Retain the letter with your laboratory records, and forward the letter to those who may have received this product.