FDA recall Z-1704-2020

Life Technologies Corporation · Class II · device

Product

Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.

Reason for recall

Extended Expiration Date prior to clearance

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2020-03-16
Report date
2020-04-22
Termination date
2021-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Frederick, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1704-2020