Siemens Dimension Tacrolimus Flex Reagent Cartridge recalled for positive bias in test results
Three lots of Siemens Dimension Tacrolimus Flex Reagent Cartridges show a potential positive bias in quality control and patient test results. This means the cartridges may report tacrolimus levels that are higher than actual values. The affected lots are FA6254, FA6260, and FA6286.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- If you operate a laboratory using this device, check whether you have cartridges from lots FA6254, FA6260, or FA6286
- Contact Siemens Healthcare Diagnostics for guidance on how to handle or return affected cartridges
- Review recent test results from these lots, especially for patients on tacrolimus therapy, in consultation with your clinical team
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 2878 units
- Illnesses reported
- None reported
- Manufactured in
- 500 Gbc Dr, N/A, Newark, DE, United States
- Classification
- Class II
- Recall number
- Z-2398-2026
In the FDA's words
- Description
- Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. 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. Affected quantity: 2878 units
- Hazard
- A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
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