FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
- Recall number
- Z-2398-2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
- Status
- Open, Classified
- Initiated
- 2026-05-07
- Posted
- 2026-06-10
- Terminated
- not on file
- Reason
- A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 2878 units
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K150168"]
- PMA numbers
- not on file
- Product code
- MLM
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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