Life Technologies Corporation: Medical Device Recall in 2018 - (Recall #: Z-1480-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

Product Classification:

Class II

Date Initiated: February 8, 2018

Date Posted: May 2, 2018

Recall Number: Z-1480-2018

Event ID: 79649

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.

Status: Terminated

Product Quantity: 30

Code Information:

Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441

Distribution Pattern:

Distributed to states: AZ, CA, NC, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated