Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Check against the official notice below — it lists the full affected range.
Life Technologies Corporation is recalling the Oncomine Dx Target Test (Model No. A32451) and Oncomine Dx Target RNA/DNA Panel (Model No. A32441), which are diagnostic tests used to detect genetic mutations in cancer patients. The recall affects 30 units of Lot 1705001 that were distributed to Arizona, California, North Carolina, Texas, and Virginia.
The RNA panel in these tests may produce inaccurate results for detecting ROS1 fusion, potentially resulting in a false negative or no result reported. If a physician relies on such an inaccurate result, the cancer drug crizotinib could be incorrectly excluded from a patient's treatment plan. The source document does not specify what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Distributed to states: AZ, CA, NC, TX, and VA. Quantity: 30 Lot/code info: Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.