Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

Siemens Healthcare Diagnostics, Inc.

The hazard

A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. FDA Class II recall.

The remedy

Follow FDA guidance

About this recall

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

Affected identifiers

Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.

Model Manufacturing Lot/Serial Numbers: FA6254Model FA6260Model FA6286Model UDIs: (01)00842768035425(10)FA6254(17)20260911Model (01)00842768035425(10)FA6260(17)20260917Model (01)00842768035425(10)FA6286(17)20261013.UPC 00842768035425

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.