Z-1705-2020Class II

Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung...

Name: Z-1705-2020 Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung...
Creator: Life Technologies Corporation
Published: 2020-03-16
License: https://open.fda.gov/license/

Life Technologies Corporation / initiated 2020-03-16 / Terminated

FDA source

Life Technologies Corporation began a recall of Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443 on 2020-03-16. FDA classified it as Class II and gives the reason as "Extended Expiration Date prior to clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1705-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-16
Posted: 2020-04-14
Terminated: 2021-03-26
Recalling firm: Life Technologies Corporation
Product: Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: Extended Expiration Date prior to clearance
FDA 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 [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]]
Quantity in commerce: 66 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Codes: S119_2174739 S119_2108428 P119_2149305 N119_2078114 S218_2069395 V118_1991154 T118_1990946 S118_1988603 P118_1996940 S117_1988306 UDI: (01)10190302006064

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1705-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1704-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-14
Z-1705-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-14
Z-1706-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-14
Z-1707-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-14

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)