CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report
Oncomine Dx Target Test recalled by Life Technologies
Life Technologies is recalling Oncomine Dx Target Test, (, distributed in Arizona, California, North Carolina, Texas, Virginia. The recall was initiated on 8 Feb 2018 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-1480-2018
- FDA event ID
- 79649
- Recalling firm
- Life Technologies, Frederick, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Feb 2018
- FDA classified
- 20 Apr 2018
- Reported
- 2 May 2018
- 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
- Test Kits & Diagnostics
Timeline
| 8 Feb 2018 | Recall initiated by company | |
| 20 Apr 2018 | Classified by FDA | +71 days |
| 2 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
Product as listed by the FDA
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Where it was distributed
Distributed to states: AZ, CA, NC, TX, and VA.
ArizonaCaliforniaNorth CarolinaTexasVirginia
Stores named: Target
Questions about this recall
Is Oncomine Dx Target Test, ( recalled?
Yes. Life Technologies recalled Oncomine Dx Target Test, ( on 8 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1480-2018.
Why was it recalled?
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
Which lots are affected?
Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
Where was it sold?
Distributed to states: AZ, CA, NC, TX, and VA.
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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