The Recall Desk
ModerateFDA (Devices)·Z-1704-2020·Announced 2020-04-22

Life Technologies Recalls Oncomine Dx Target Test DNA Control-IVD

Life Technologies is recalling 66 units of Oncomine Dx Target Test DNA Control-IVD 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 specific issue is a documentation and labeling error (extended expiration date) with no 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 DNA Control-IVD, Catalog Number A32442. This product 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 product was extended prior to clearance. The affected units were distributed nationwide in the United States.

Healthcare facilities and laboratories should stop using the affected units and contact Life Technologies Corporation for instructions on return or disposal.

The recalled product

Product
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.
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.

See all 4 products in this recall →