Siemens Dimension Sirolimus Reagent Cartridge Recalled for Stability Failure
Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges due to open well instability that may cause inaccurate test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 394 units of the Dimension clinical chemistry system Sirolimus (SIRO) Flex reagent cartridge, Lot EB6064. The product is an in vitro diagnostic test used for the quantitative measurement of sirolimus in whole blood.
The recall was initiated after the company received customer complaints regarding quality control shifts and imprecision occurring after one day of use. Siemens confirmed that the affected lot does not meet the open well stability claim of 2 days.
The affected product was distributed worldwide and in the United States, including Puerto Rico and the states of Texas, Florida, California, Louisiana, the District of Columbia, Georgia, Illinois, Arkansas, Wisconsin, Michigan, and Maryland. Users should stop using the affected lot and contact Siemens Healthcare Diagnostics for instructions on replacement or return.
The recalled product
- Product
- Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 394
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 (1)
- Lot # EB6064
Distribution
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