Ion Torrent Dx Control Kit (Life Technologies) – Expiration Extension (2020)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Extended Expiration Date prior to clearance

Recommended Action

Per FDA guidance

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-month corrected expiration date per Attachment 1: Discontinue use of the product, record the kit lot numbers and quantities impacted on the attached Customer Response Sheet, and email the completed response sheet to gabriella.armin@thermofisher.com. For products that are still within the 9-month corrected expiration date per Attachment 1: Correct the expiration dating on the product labelling within your inventory by reviewing Attachment 1 to determine the correct expiration date per kit lot. Strike through the incorrect expiration date and add the new one using permanent ink or amend the label by adding an additional label correcting the expiration date on the labelling. The updated labelled product can continue to be used until the 9-month expiration date, after which any remaining product should be discarded. Note: If affected product was used past the 9-month corrected expiration date per Attachment 1, but before the 12-month expiration date on the kit labels, there is no anticipated risk of generating inaccurate/incorrect results because the system will inform the user if the assay did not meet run passing criteria and test results wont be generated. Therefore, no action on your part is required. If you have any technical questions or concerns, please contact Technical Support at [NA --800-955-6288 option 4 or techsupport@thermofisher.com]