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
Check against the official notice below — it lists the full affected range.
Life Technologies Corporation is recalling 79 units of the Ion Torrent Dx No Template Control Kit, a diagnostic test used to detect DNA and RNA from non-small cell lung cancer tumor specimens. The recall was issued because certain lot codes were assigned expiration dates that exceeded the product's approved shelf life. Two specific lots were mislabeled with a 24-month expiration date when the approved shelf life is only 9 months, and two additional lots had kit-level labeling showing a 12-month expiration date, which also exceeds the approved duration.
The affected product was distributed nationwide in the United States. The recall involves 12 specific lot codes, which are identified in the FDA record. The source document does not specify a remedy or recommended action for consumers who may have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Extended Expiration Date prior to clearance
Reason for recall: Extended Expiration Date prior to clearance Distribution: US Nationwide distribution. Quantity: 79 units Lot/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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.