FDA Medical Device Recalls (openFDA)
Life Technologies Corporation: 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
- Recall number
- Z-1706-2020
- Recalling firm
- Life Technologies Corporation
- Product
- 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
- Status
- Terminated
- Initiated
- 2020-03-16
- Posted
- not on file
- Terminated
- 2021-03-26
- 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-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]
- Quantity
- 35 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Codes: S119_2174743 S119_2188760 S119_2165333 P119_2149298 S217_04001 1705002 UDI: (01)10190302015103
- 510(k) numbers
- not on file
- PMA numbers
- ["P160045"]
- Product code
- PQP
- Firm FEI
- 3003335080
- Firm city
- Frederick
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28