Recall Z-1924-2013 ยท MLM Enzyme Immunoassay, Tracrolimus
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Aug 7, 2013 (initiated Jul 1, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root 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 anyo |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060502 | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 Dade Behring, Inc., May 18, 2006 |