[pending] Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoass
Pending LLM rewrite. Source: FDA_DEVICE Z-2398-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
The recalled product
- Product
- Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distributed nationwide across the United States.
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