Life Technologies Recalls Oncomine Dx Target Test Due to Expiration Date Error
Life Technologies is recalling 35 units of the Oncomine Dx Target Test because the expiration date was extended prior to clearance.
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, but the source text identifies the issue as a documentation/labeling error (expiration date) without reporting any illnesses, injuries, or adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Life Technologies Corporation is recalling 35 units of the Oncomine Dx Target Test RNA/DNA Panel, Catalog Number A32441. This in vitro diagnostic (IVD) device is used for the detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens.
The recall was initiated because the expiration date for the affected units was extended prior to clearance. The affected lots are S119_2174743, S119_2188760, S119_2165333, P119_2149298, S217_04001, and 1705002. The product was distributed nationwide in the United States.
Healthcare providers and laboratories should stop using the affected units and contact Life Technologies Corporation for further instructions regarding the recall.
The recalled product
- Product
- Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441
- Manufacturer
- Life Technologies Corporation
- Hazard
- Affected units
- 35
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Life Technologies Corporation 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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