Z-1258-2023Class II

Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement...

Name: Z-1258-2023 Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2023-01-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-01-30 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension... on 2023-01-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1258-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-30
Posted: 2023-03-15
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)
Product code: MLM Enzyme Immunoassay, Tracrolimus
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).
FDA 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 in commerce: 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
Product codes and lots: UDI: 00842768035425GA228622101310700795840, 00842768035425GA304723021610700795840, 00842768035425GA317123062010700795840. Lot Numbers: GA2286, GA3047, GA3171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1258-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1258-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-15

Product code MLM

K150168Class IIDimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)Siemens Healthcare Diagnostics / cleared 2015-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)