Ion Torrent Dx No Template Control Kit- IVD for recall
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…
Why was Ion Torrent Dx No Template Control Kit- IVD for recalled?
Extended Expiration Date prior to clearance
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Life Technologies Corporation
- Quantity
- 79 units
- Distribution
- US Nationwide distribution.
- Recall date
- April 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)