Recall Z-1258-2023 · MLM Enzyme Immunoassay, Tracrolimus
Siemens Healthcare Diagnostics, Inc.
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)
| Date | Mar 15, 2023 (initiated Jan 30, 2023) |
| Status | Open, Classified |
| 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 patie |
| Root cause | Under Investigation by firm |
| Action | Siemens issued to US Customers Urgent Medical Device Correction (DC-23-03.A.US) via FedEx beginning on 01/30/2023. OUS Customers sent Urgent Field Safety Notice (DC-23-03.A.OUS). Letter states reason for recall, health risk and action to take: Discontinue use and discard the lots listed in Table 1 and complete the attached Product Replacement form for no-charge product replacement. Please note, lot GA2286 is expired. Review your inventory to determine possible replacement needs and provide information to Siemens for reporting to the Authorities. Please review this letter with your Medical D |
| Quantity | 6035 units |
| 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 |
| 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 |