Siemens Healthineers recalls Dimension Tacrolimus (TAC) Flex reagent cartridges with lots GA2286, GA3047, and GA3171 due to imprecision causing potential organ failure or toxicity from incorrect tacrolimus dosing.
Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential organ failure and rejection (due to too low or no tacrolimus being administered) or toxicity (due to too much tacrolimus being administered). Siemens internal investigation of the Dimension TAC assay showed the worst case imprecision with patient samples at the low end of the Analytical Measurement Range (AMR). A patient sample at 2.0 ng/mL (2.6 nmol/L) recovered as 0.0 ng/mL (0.0 nmol/L) (100% negative bias), another patient sample at 2.1 ng/mL (2.7 nmol/L) recovered at 4.3 ng/mL (5.6 nmol/L) (103% positive bias).
Siemens Healthineers is recalling Dimension Tacrolimus (TAC) Flex reagent cartridges with specific lot numbers because they can produce inaccurate test results. This could lead to patients receiving too much or too little tacrolimus, risking organ failure or toxicity.
The recalled cartridges can produce significantly inaccurate results, especially at low tacrolimus levels. For example, a sample at 2.0 ng/mL may show as 0.0 ng/mL, while another at 2.1 ng/mL may show as 4.3 ng/mL. This error could lead to improper dosing, causing organ damage from too little or too much tacrolimus.
Patients using the Dimension Tacrolimus (TAC) Flex reagent cartridges for tacrolimus level testing are affected. Those with immunosuppressant therapy requiring precise tacrolimus dosing are at highest risk.
Check the lot number on the cartridge label: GA2286, GA3047, or GA3171. These cartridges were sold with the Dimension clinical chemistry system model SMN: 10700795 (DF207).
Look for the lot number on the cartridge label: GA2286, GA3047, or GA3171.
Siemens Healthineers received customer complaints and confirmed imprecision in the Dimension Tacrolimus (TAC) Flex reagent cartridges with specific lot numbers, which could lead to incorrect tacrolimus dosing.
Using these cartridges could result in inaccurate tacrolimus measurements, potentially causing organ failure from too little tacrolimus or toxicity from too much tacrolimus.
Check the lot number on the cartridge label: GA2286, GA3047, or GA3171. These were sold with the Dimension clinical chemistry system model SMN: 10700795 (DF207).
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-1258-2023 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-1258-2023 from Siemens Healthineers. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
