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)

Recall number

Z-1258-2023

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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)

Status

Open, Classified

Initiated

2023-01-30

Posted

2023-03-15

Terminated

not on file

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).

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 Director and the decision on a review of previously generated results. If you receive any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Remote Services Center or your local Siemens Technical Support Representative. Complete and return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities. Questions, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.

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

Lot, serial or model codes

UDI: 00842768035425GA228622101310700795840, 00842768035425GA304723021610700795840, 00842768035425GA317123062010700795840. Lot Numbers: GA2286, GA3047, GA3171

510(k) numbers

["K150168"]

PMA numbers

not on file

Product code

MLM

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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