Reported May 2, 2018 · Terminated
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In…
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?
- Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
- Lot codes and dates
- Lot 1705001 UDI(01)10190302006385(17)180220(10)1705001(240)A32441
- Amount recalled
- 30
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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