FDAClass IIApril 22, 2020

Oncomine Dx Target Test RNA Control- IVD for detection recall

Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog…

Why was Oncomine Dx Target Test RNA Control- IVD for detection recalled?

Extended Expiration Date prior to clearance

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Life Technologies Corporation
Quantity
66 units
Distribution
US Nationwide distribution.
Recall date
April 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls