FDA Enforcement
Class II
Terminated
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
Recall: Z-1707-2020
·
Reported April 22, 2020
Enforcement
- Recall Number
- Z-1707-2020
- Event ID
- 85203
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Life Technologies Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- April 22, 2020
- Initiation Date
- March 16, 2020
- Classification Date
- April 14, 2020
- Termination Date
- March 26, 2021
- Address
- 7335 Executive Way, Frederick, MD, 21704-8354, United States
Description
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
Reason
Extended Expiration Date prior to clearance
Code Info
Lot Codes: S119_2174740* S119_2108429* P119_2149308 N119_2078115 S218_2069396 V118_1991155 T118_1990947 S217_2008385 S118_1988604 P118_1996942 N118_1974439 S117_1988308 * Mislabeled with a 24-month expiration date. However, the approved shelf life of the vials is also 9 months. Please note, the kit level labelling for the two impacted lots of Ion Torrent Dx No Template Control kit shows a 12-month expiration date, which is also incorrect UDI: (01)10190302006156
Distribution
US Nationwide distribution.
Quantity
79 units