Urgent Field Safety Notice For Disopyramide Assay And Emit Tox Serum Tricyclic Antidepressants By Siemens Healthcare Diagnostics Inc. Newark

Recall Summary Siemens Healthcare Diagnostics is issuing an urgent safety notice for two laboratory test products: the Disopyramide Assay and Emit tox Serum Tricyclic Antidepressants test. These products were distributed in Germany and the EU. This is classified as a Class I safety issue, indicating a serious problem with the products.

Recalling firm
Siemens Healthcare Diagnostics Inc. Newark
Product
Disopyramide Assay and Emit tox Serum Tricyclic Antidepressants
Reason
Urgent Field Safety Notice for Disopyramide Assay and Emit tox Serum Tricyclic Antidepressants by Siemens Healthcare Diagnostics Inc. Newark
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-07-27
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/94d19cb2-eaa7-4451-afde-3c66d8d17af3