Life Technologies Recalls Oncomine Dx Target Test RNA Control for Expiration Date Error
Life Technologies is recalling 66 units of the Oncomine Dx Target Test RNA Control because the expiration date was extended prior to regulatory clearance.
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 specific hazard is a documentation and labeling error (extended expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Life Technologies Corporation is recalling 66 units of the Oncomine Dx Target Test RNA Control, an in vitro diagnostic (IVD) used for the detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens. The product is identified by Catalog Number A32443 and UDI (01)10190302006064.
The recall was initiated because the expiration date for the product was extended prior to clearance by the U.S. Food and Drug Administration. This constitutes a labeling and regulatory compliance issue regarding the product's shelf life.
The affected units were distributed nationwide in the United States. Specific lot codes associated with this recall include S119_2174739, S119_2108428, P119_2149305, N119_2078114, S218_2069395, V118_1991154, T118_1990946, S118_1988603, P118_1996940, and S117_1988306. Users of this product should contact Life Technologies Corporation for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443
- Manufacturer
- Life Technologies Corporation
- Affected units
- 66
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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