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.
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 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Life Technologies Corporation
See all →- HighTorrent Suite Dx Software versions affected by cybersecurity vulnerability
FDA (Devices) · 2024-04-10
- HighLife Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software
FDA (Devices) · 2020-09-23
- HighLife Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software
FDA (Devices) · 2020-09-23
- ModerateLife Technologies Recalls Ion Torrent Dx No Template Control Kit
FDA (Devices) · 2020-04-22
- ModerateLife Technologies Recalls Oncomine Dx Target Test RNA Control for Expiration Date Error
FDA (Devices) · 2020-04-22
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighLife Technologies Recalls Oncomine Dx Target Test User Guides
FDA (Devices) · 2018-04-11
- HighLife Technologies Recalls Oncomine Dx Target Test Due to False Negative Risk
FDA (Devices) · 2018-05-02
- ModerateMenarini Silicon Biosystems Recalls CellSearch Circulating Tumor Cell Kits
FDA (Devices) · 2018-05-02
- HighCELLSEARCH Circulating Tumor Cell Kit Recalled for False Positive Risk
FDA (Devices) · 2022-07-13
- ModerateCook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Incorrect Expiration Dates
FDA (Devices) · 2020-04-01
- ModerateAngiodynamics Recalls Xcela Power Injectable PICCs with Incorrect Expiration Dates
FDA (Devices) · 2018-12-19