Z-1480-2018Class II

Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A...

Name: Z-1480-2018 Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A...
Creator: Life Technologies Corporation
Published: 2018-02-08
License: https://open.fda.gov/license/

Life Technologies Corporation / initiated 2018-02-08 / Terminated / root cause: manufacturing process

FDA source

Life Technologies Corporation began a recall of Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test on 2018-02-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1480-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-08
Posted: 2018-04-20
Terminated: 2020-05-12
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.
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. Questions and comments should be directed to Vineet Bansal, 408-802-2341, [email protected].
Quantity in commerce: 30
Distribution: Distributed to states: AZ, CA, NC, TX, and VA.
Product codes and lots: Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1480-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1480-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20

Product code PQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)