Urgent Field Safety Notice For Dimension Tacrolimus (tacr) Flex Reagent Cartridge (-calibrator Dc107) By Siemens Healthcare Diagnostics Inc. Newark

Recall Summary Siemens Healthcare Diagnostics is recalling Dimension Tacrolimus (TACR) Flex reagent cartridges with Calibrator DC107 used in medical testing systems. The cartridges have an unspecified safety issue that prompted an urgent recall. The affected products were distributed in Germany and the EU.

Recalling firm
Siemens Healthcare Diagnostics Inc. Newark
Product
Dimension Tacrolimus (TACR) Flex reagent cartridge (-Calibrator DC107)
Reason
Urgent Field Safety Notice for Dimension Tacrolimus (TACR) Flex reagent cartridge (-Calibrator DC107) by Siemens Healthcare Diagnostics Inc. Newark
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-06-03
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/98ea1cd3-c23a-4403-9d71-3e1b5cc589e6