Skip to content

Oncomine Dx Target Test recallZ-1706-2020 · Life Technologies Corporation · initiated Mar 16, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Life Technologies Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Extended Expiration Date prior to clearance

FDA root cause category: Incorrect or no expiration date

What the company is doing

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 [email protected]. 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 [email protected]]

Recall details

Recall number
Z-1706-2020
Status
Terminated
Initiated by the company
Mar 16, 2020
Recalling firm
Life Technologies Corporation
Quantity
35 units
Product code
PQP
FDA submissions
P160045
Distribution
US Nationwide distribution.

Product description

Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441

Code information (models, lots, serial numbers)

Lot Codes: S119_2174743 S119_2188760 S119_2165333 P119_2149298 S217_04001 1705002  UDI: (01)10190302015103

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under P160045 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85203).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page