Recall Z-1480-2018— Life Technologies Corporation
Class II · Terminated
Class II FDA medical device recall by Life Technologies Corporation, initiated 2018-02-08, terminated 2020-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.. Reason: The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen..
- Recalling firm
- Life Technologies Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-08
- Terminated
- 2020-05-12
- Firm location
- Frederick, MD, United States
Product description
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Reason for recall
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
Data sourced from openFDA. This site is unofficial and independent of the FDA.