Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC)… recallZ-2398-2026 · Siemens Healthcare Diagnostics, Inc. · initiated May 7, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
FDA root cause category: Under Investigation by firm
What the company is doing
Siemens Healthineers issued an Urgent Medical Device Correction notice to its consignees on 5/12/2026 via FedEx. The notice described the issue, its impact to QC and patient results, and requested the following: "Customer Actions . Immediately discontinue use of and discard the affected kit lot numbers. . Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. . Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for required regulatory reporting. . Complete and return the Field Correction Effectiveness Check Form attached to this letter within (30) days. . Please retain this letter with your laboratory records and forward it to anyone who may have received or used this product." For questions, contact your Siemens Healthineers Customer Care Center at (312) 275-7795 or your local Siemens Healthineers technical support representative.
Recall details
- Recall number
- Z-2398-2026
- Status
- Open, Classified
- Initiated by the company
- May 7, 2026
- Posted by the FDA
- Jun 10, 2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 2878 units
- Product code
- MLM
- FDA submissions
- K150168
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Brazil, Croatia, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Pakistan, Poland, Saudi Arabia, Spain, South Africa, Sri Lanka, Turkey, United Arab Emirates.
Product description
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Code information (models, lots, serial numbers)
Manufacturing Lot/Serial Numbers: FA6254, FA6260, FA6286; UDIs: (01)00842768035425(10)FA6254(17)20260911; (01)00842768035425(10)FA6260(17)20260917; (01)00842768035425(10)FA6286(17)20261013.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dimension® Flex® reagent cartridge TAC 10700795Siemens Healthcare Diagnostics Inc. · ENZYME IMMUNOASSAY, TRACROLIMUS2 recalls121 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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