FDA Medical Device Recalls (openFDA)
Life Technologies Corporation: Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
- Recall number
- Z-1480-2018
- Recalling firm
- Life Technologies Corporation
- Product
- Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
- Status
- Terminated
- Initiated
- 2018-02-08
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 30
- Distribution
- Distributed to states: AZ, CA, NC, TX, and VA.
- Lot, serial or model codes
- Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
- 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