Siemens Dimension Sirolimus Reagent Cartridge Recalled for Biotin Interference
Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges because biotin can interfere with test results, potentially affecting patient care.
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: The recall is classified as FDA Class II and involves a risk of harm (inaccurate test results due to biotin interference) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Sirolimus (SIRO) Flex reagent cartridges. The recall is due to the fact that the instruction for use does not currently list the specific concentrations of biotin that do not interfere with the test. As a result, the assay is susceptible to interference from biotin, which may affect the accuracy of the test results.
The affected product is the Dimension Sirolimus (SIRO) Flex reagent cartridge, identified by the code SIRO and SMN# 10464331. Specific lot codes included in the recall are BB7336, FA8037, FA8081, BB8167, FB8177, and FB8219. The product was distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand.
Healthcare facilities and laboratories should stop using the affected reagent cartridges and contact Siemens Healthcare Diagnostics for instructions on how to return the product. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (4)
- SIRO
- sirolimus test system
- DF306
- SMN# 10464331 Lot codes: BB7336 FA8037 FA8081 BB8167 FB8177 FB8219
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · test interference
See all →- HighSiemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results
FDA (Devices) · 2024-04-24
- HighFetal Membrane Rupture Test Kits Recalled for False Positive Results
FDA (Devices) · 2024-04-24
- HighAbbott Alinity i Anti-HCV Reagent Kit Recall for Falsely Elevated Test Results
FDA (Devices) · 2024-04-10
- HighHepatitis B Diagnostic Test Kits Recalled for Test Interference
FDA (Devices) · 2023-03-01
- HighFDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination
FDA (Devices) · 2022-06-15