Recall Z-2398-2026 · MLM Enzyme Immunoassay, Tracrolimus
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
| Date | Jun 10, 2026 (initiated May 7, 2026) |
| Status | Open, Classified |
| Reason | A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthineers issued an Urgent Medical Device Correction notice to its consignees on 5/12/2026 via FedEx. The notice described the issue, its impact to QC and patient results, and requested the following: "Customer Actions . Immediately discontinue use of and discard the affected kit lot numbers. . Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. . Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Si |
| Quantity | 2878 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Brazil, Croatia, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Pakistan, Poland, Saudi Arabia, Spain, South Africa, Sri Lanka, Turkey, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) Siemens Healthcare Diagnostics, Nov 4, 2015 |