Class 2 Device Recall DimensionTACR (DF107) and Dimension Tacrolimus Calibrator (DC107)

• Date Initiated by Firm: July 01, 2013
• Date Posted: August 07, 2013
• Recall Status: Terminated on August 26, 2014
• Recall Number: Z-1924-2013
• Recall Event ID: 65706
• 510(K)Number: K060502
• Product Classification: Enzyme immunoassay, tracrolimus - Product Code MLM
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr Ms 514; PO BOX 6101; Newark DE 19702-2466
• For Additional Information Contact: Siemens Customer Service; 800-441-9250
• Manufacturer Reason for Recall: Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.
• FDA Determined Cause: Process control
• Action: Siemens sent an Urgent Medical Device Recall letter dated July 2013 to affected customers The letter identified the affected product, problem, potential risk, and actions to be taken by customers. Customers were requested to discuss the letter with thier laboratory director to determine if additional follow up is appropriate for patient tests conducted with the affected device lots. Additionally, customers were asked to discard any remaining inventory and to complete and return the field correction effectiveness check for replacement product. They were also asked to forward the letter to anyone wha had received this affected product. For questions contact your Siemens Technical Solutions Center or your local Siemens Technical support representative.
• Quantity in Commerce: 5423
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MLM