Dimension Tacrolimus — Class II medical device recall Z-1258-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2023-03-22, distributed nationwide. Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and p
| Recall number | Z-1258-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2023-01-30 |
| Classified | 2023-03-15 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CL, CO, ES, IN, JP, KR, LK, NI, NZ, TW, ZA |
| Quantity | 6,035 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00842768035425 |
| Lot numbers | GA2286, GA3047, GA3171 |
Product
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1258-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.