Recall Z-1707-2020 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Life Technologies Corporation
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
| Date | Mar 16, 2020 |
| Status | Terminated |
| Reason | Extended Expiration Date prior to clearance |
| Root cause | Incorrect or no expiration date |
| Action | Thermo Fisher issued notification on 3/16/20 via email followed by hard copy on 3/18/20, stating reason for recall, health risk and action to take: Review the expiration date of the products referenced in the table included in the Customer Notification and take the following actions: "Notify all Oncomine Dx Target Test users in your facility of this issue. "Review the expiration date of the products referenced in the table above and using Attachment 1 of this letter, take the following actions. Attachment 1 provides the corrected expiration dates per lot. For products that are past the 9-mont |
| Quantity | 79 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.