Reported Apr 22, 2020 · Terminated
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer…
Life Technologies Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Life Technologies Corporation · 7335 Executive Way · Frederick, MD · 21704-8354
Is this the product you have?
- 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 NumberA32444
- Lot codes and dates
- Lot CodesS119_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
- Amount recalled
- 79 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Extended Expiration Date prior to clearance
This product could cause temporary or reversible health problems — stop using it.
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