FDA Device recall Z-1258-2023
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole bl…
- FDA Device
- Class II
- ongoing
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class II recall of Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole bl… by Siemens Healthcare Diagnostics, citing siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1258-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-30 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
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).
Identifiers
| code_info | UDI: 00842768035425GA228622101310700795840, 00842768035425GA304723021610700795840, 00842768035425GA317123062010700795840. Lot Numbers: GA2286, GA3047, GA3171 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1258-2023%22
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