Life Technologies Recalls Oncomine Dx Target Test Due to False Negative Risk
Life Technologies is recalling 30 units of the Oncomine Dx Target Test because a lower RNA concentration could cause false negative results for ROS1 fusion, potentially affecting patient treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where injury or adverse health consequences have not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Life Technologies Corporation is recalling 30 units of the Oncomine Dx Target Test (Model No. A32451) and Oncomine Dx Target RNA/DNA Panel (Model No. A32441). The recall involves Lot 1705001, which was distributed to Arizona, California, North Carolina, Texas, and Virginia.
The recall was initiated because a lower concentration of the RNA panel could result in a 'NO CALL' or 'FALSE NEGATIVE' for the reporting of ROS1 fusion. If a physician relies on a false negative result, the medication crizotinib could be improperly excluded from a patient's treatment regimen.
Healthcare providers and laboratories should stop using the affected product and contact Life Technologies Corporation for further instructions. Patients who may have received test results from this specific lot should consult their healthcare provider to discuss their treatment options.
The recalled product
- Product
- Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
- Manufacturer
- Life Technologies Corporation
- Affected units
- 30
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 (1)
- Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
Distribution
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