Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00839-1
Product Name/Description Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD)

Assays: Ammonia, Alanine Aminotransferase, Aspartate Aminotransferase, Glucose, Creatine Kinase MB and Thyroxine.

Multiple Test Codes and Catalogue Numbers

All Lots

ARTG Numbers: 181689, 181688, 182776, 180109
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/07/2017
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.

This action has been closed out on 09/07/2019
Contact Information 1800 310 300 - Siemens Technical Support Centre