FDAClass II · Medical device · Recalled June 17, 2026
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC) recall — Siemens Healthcare Diagnostics, Inc.
Hazard: A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2398-2026
- Brand
- Siemens Healthcare Diagnostics
- Classification
- Class II
- Units affected
- 2878 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Affected products
Companies & origin
- Recalling firm location
- Newark, DE, United States
- Firm address
- 500 Gbc Dr, N/A, 19702-2466
Identifying details (verbatim from the notice)
- Product codes / lots
- 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.
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 98985
- Recall initiated
- May 7, 2026
- FDA classified
- June 10, 2026
- FDA report date
- June 17, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 1:09 AM UTC.
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