Siemens Lipase Reagent Cartridge Recall for Lot Variability
Siemens Healthcare is recalling specific lots of Dimension Lipase Flex Reagent Cartridges due to lot-to-lot variability affecting quality control and patient results.
What this means for you
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, and the hazard involves potential diagnostic inaccuracy due to lot variability without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 18,396 units of the Dimension Lipase Flex Reagent Cartridge, Model Number 10460277. The affected lot numbers are GD9002, GA9003, GB9032, and GA9038. These products were distributed worldwide, including in the United States and numerous foreign countries.
The recall was initiated because there is lot-to-lot variability for quality control and patient results when using the identified reagent cartridge lots. The product is an in vitro diagnostic test used for the quantitative measurement of lipase in human serum and plasma on the Dimension clinical chemistry system.
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 18,396
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)
- Lot Numbers: GD9002
- GA9003
- GB9032
- GA9038
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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