Reported Jun 17, 2026 · Ongoing
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr · Newark, DE · 19702-2466
Is this the product you have?
- Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
- Lot codes and dates
- Manufacturing Lot/Serial Numbers
FA6254FA6260FA6286
- UDIs
(01)00842768035425(10)FA6254(17)20260911(01)00842768035425(10)FA6260(17)20260917(01)00842768035425(10)FA6286(17)20261013
- Manufacturing Lot/Serial Numbers
- Amount recalled
- 2878 units
Where it was sold
- Nationwide
Why it was recalled
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
This product could cause temporary or reversible health problems — stop using it.
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