The Recall Desk
ModerateFDA (Devices)·Z-1707-2020·Announced 2020-04-22

Life Technologies Recalls Ion Torrent Dx No Template Control Kit

Life Technologies is recalling 79 units of the Ion Torrent Dx No Template Control Kit due to extended expiration dates prior to clearance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Life Technologies Corporation is recalling 79 units of the Ion Torrent Dx No Template Control Kit, Catalog Number A32444. This in vitro diagnostic (IVD) product is used for the detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens. The recall was initiated because the product had an extended expiration date prior to clearance.

The affected lots include S119_2174740, S119_2108429, P119_2149308, N119_2078115, S218_2069396, V118_1991155, T118_1990947, S217_2008385, S118_1988604, P118_1996942, N118_1974439, and S117_1988308. Some lots were mislabeled with a 24-month expiration date, although the approved shelf life of the vials is 9 months. Additionally, the kit-level labeling for two impacted lots showed a 12-month expiration date, which is also incorrect. The product was distributed nationwide in the United States.

Healthcare facilities and laboratories should stop using the affected products and contact Life Technologies Corporation for further instructions or a return. This recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

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
Affected units
79

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • the approved shelf life of the vials is also 9 months. Please note
  • which is also incorrect UDI: (01)10190302006156

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Life Technologies Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →