FDA Device recall Z-1707-2020
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens C…
- FDA Device
- Class II
- terminated
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens C… by Life Technologies, citing extended Expiration Date prior to clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1707-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-16 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Life Technologies |
| Distribution | US |
Product
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
Identifiers
| code_info | Lot Codes: S119_2174740* S119_2108429* P119_2149308 N119_2078115 S218_2069396 V118_1991155 T118_1990947 S217_20…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1707-2020%22
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