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Lower risk Medical device recall · FDA · Published March 16, 2020

Life Technologies Oncomine DNA Control Recall: Extended Expiration Date Risk

Life Technologies recalls Oncomine Dx Target Test DNA Control-IVD for NSCLC detection due to extended expiration date prior to clearance. Affected lots may expire before intended use.

🇺🇸 FDA recall #Z-1704-2020Medical deviceLife Technologies ›
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Recalling firmLife Technologies Corporation7335 Executive Way · Frederick, MD 21704-8354
✎ GovInfoNow plain-language explainer

Life Technologies is recalling a DNA control test for non-small cell lung cancer detection because the expiration date may extend beyond the time it's cleared for use. This could lead to inaccurate results if the test is used after it expires. Read more at govinfonow.com/recall/65653-life-technologies-oncomine-dna-control-recall-extended-expiration-date-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65653-life-technologies-oncomine-dna-control-recall-extended-expiration-date-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1704-2020

Cite this page

“Life Technologies Oncomine DNA Control Recall: Extended Expiration Date Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65653-life-technologies-oncomine-dna-control-recall-extended-expiration-date-risk. Based on FDA recall #Z-1704-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1704-2020%22&limit=1).

Life Technologies Corporation voluntarily recalled Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) due to an extended expiration date prior to clearance, the FDA said on March 16, 2020.

How to tell if you have it

  • Brand: Life Technologies
  • Product: Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC)
  • Catalog Number: A32442
  • Lot Codes: S119_2174741, S119_2161574, P119_2149301, N119_2078113, S218_2069394, V118_1991153, T118_1990945, S217_2008383, S118_1988602, P118_1996941, S117_1988305
  • UDI: (01)10190302006095
  • UPC: 10190302006095
  • Distribution: US Nationwide

The hazard

The recall involves an extended expiration date prior to clearance for the Oncomine Dx Target Test DNA Control-IVD. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Life Technologies Corporation has 6 other recalls on record since December 4, 2017. Other recent recalls of similar products include Life Technologies Torrent Suite Dx Software 5.14 Recall (February 7, 2024), Life Technologies Recalls COVID-19 Test Software (August 6, 2020), and Life Technologies CTSTM Essential 8 Medium Recall (June 11, 2019). Other recent recalls of similar products include Cook Staged Extubation Set (March 5, 2026), Cook Medical Multipurpose Drainage Catheter Recall (March 5, 2026), and GET TESTED Biological Age Test (November 3, 2025).

How to tell if you have this one

Check the lot codes: S119_2174741, S119_2161574, P119_2149301, N119_2078113, S218_2069394, V118_1991153, T118_1990945, S217_2008383, S118_1988602, P118_1996941, S117_1988305. The product was sold with a specific expiration date that may extend beyond clearance.

  • Brand
    Life Technologies
  • Product
    Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC)
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-1704-2020Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.; Lot Codes: S119_2174741 S119_2161574 P119_2149301 N119_2078113 S218_2069394 V118_1991153 T118_1990945 S217_2008383 S118_1988602 P118_1996941 S117_1988305 UDI: (01)1019030200609566 units
Z-1705-2020Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443; Lot Codes: S119_2174739 S119_2108428 P119_2149305 N119_2078114 S218_2069395 V118_1991154 T118_1990946 S118_1988603 P118_1996940 S117_1988306 UDI: (01)1019030200606466 units
Z-1706-2020Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441; Lot Codes: S119_2174743 S119_2188760 S119_2165333 P119_2149298 S217_04001 1705002 UDI: (01)1019030201510335 units
Z-1707-2020Ion 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; 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)1019030200615679 units
Based on the official FDA remedy

What to do — step by step

  1. Check Expiration Date

    Verify the expiration date on the test kit against the intended use date to ensure it hasn't expired.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Mar 16, 202012. FDA classified it Class II: Apr 14, 202023. Published in FDA’s Enforcement Report: Apr 22, 202034. FDA terminated the recall: Mar 26, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1704-2020 (March 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1704-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA