Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
This recall has been terminated (originally issued February 8, 2018).
- Company
- Life Technologies Corporation
- Recall Initiated
- February 8, 2018
- Terminated
- May 12, 2020
- Recall Number
- Z-1480-2018
- Quantity
- 30
- Firm Location
- Frederick, MD
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
Root Cause
Process control
Action Taken
The firm issued an Urgent: Medical Device Recall Notification, dated February 16, 2018, via e-mail and phone call to affected consignees. The letter identified the affected device and advised customers of the potential "No Call" or false positive outcomes. Users were advised that they may need an alternate method to determine the presence of ROS1 variant in previously tested patient samples, and that any future tests using the affected lot cannot be considered valid if "No Call" or "Negative" is the result. Requested action included reviewing previous results which used the affected lot. Customers are to complete the Customer Response Sheet provided and e-mail a scanned copy along with the letter to vineet.bansal1@thermofisher.com. Questions and comments should be directed to Vineet Bansal, 408-802-2341, vineet.bansal1@thermofisher.com.