- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 2878 units
- Distribution pattern
- 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 location
- Newark, DE, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2398-2026
- Recall initiated
- May 7, 2026
- FDA classification date
- June 10, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98985
- Last updated on HTM Vibe
- July 23, 2026