CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report
Oncomine Dx Target Test RNA/DNA Panel- IVD recalled by Life Technologies
Life Technologies is recalling Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from, distributed nationwide in the US. The recall was initiated on 16 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1706-2020
- FDA event ID
- 85203
- Recalling firm
- Life Technologies, Frederick, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Mar 2020
- FDA classified
- 14 Apr 2020
- Reported
- 22 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Mar 2020 | Recall initiated by company | |
| 14 Apr 2020 | Classified by FDA | +29 days |
| 22 Apr 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Extended Expiration Date prior to clearance
Product as listed by the FDA
Oncomine 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
Where it was distributed
US Nationwide distribution.
Stores named: Target
Questions about this recall
Is Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from recalled?
Yes. Life Technologies recalled Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from on 16 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-1706-2020.
Why was it recalled?
Extended Expiration Date prior to clearance
Which lots are affected?
Lot Codes: S119_2174743 S119_2188760 S119_2165333 P119_2149298 S217_04001 1705002 UDI: (01)10190302015103
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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