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 Dimension Tacrolimus (TAC) Flex Cartridge Recall: Erroneous Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58997-siemens-healthineers-dimension-tacrolimus-tac-flex-cartridge-recall-erroneous-results. Based on FDA recall #Z-1258-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1258-2023%22&limit=1).
The FDA announced on Jan. 30, 2023, that Siemens Healthineers is recalling Dimension Tacrolimus (TAC) Flex reagent cartridges due to imprecision risks. The agency stated the recall affects approximately 6,035 units distributed worldwide and nationwide.
Siemens Healthineers confirmed imprecision for Quality Control and patient samples in the affected lots. The agency warned that erroneous results could lead to altered tacrolimus dosing, potentially causing organ failure, rejection, or toxicity.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls since June 7, 2017. Recent brand recalls include the Atellica CH RCRP Test on Aug. 17, 2026, and the Syva EMIT 2000 Quinidine Assay on July 13, 2026. Other recent recalls of similar products include HardyDisk AST Cefiderocol (June 8, 2026), Exploro Fertility Test (Nov. 22, 2025), and Vivoo Test Strips (Nov. 22, 2025).
How to tell if you have this one
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).
Brand
Siemens Healthineers
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cartridge Lot Number
Look for the lot number on the cartridge label: GA2286, GA3047, or GA3171.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide and Nationwide Distribution Foreign: Aregentina Brazil Chile Colombia Country India Japan New Zealand Nicaragua Saudi¿Arabia¿¿¿ South Africa South Korea Spain¿¿¿¿¿¿¿¿¿¿ Sri Lanka Taiwan” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1258-2023 (January 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1258-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.