Devices

Device Recall DimensionTACR (DF107) and Dimension Tacrolimus Calibrator (DC107)

Model / Serial
TACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiration date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
USA Nationwide Distribution including the states of: TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN.
Product Description
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) || Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall DimensionTACR (DF107) and Dimension Tacrolimus Calibrator (DC107)

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)