Oncomine Dx Target TestRecalls & reported problems across all models

We found 2 models of Oncomine Dx Target Test by Life Technologies Corporation in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Feb 23, 2018 and Feb 23, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (1 report).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Oncomine Dx Target Test recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 16, 2020Terminated

   Extended Expiration Date prior to clearance

   Z-1706-2020 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

2. Feb 8, 2018Terminated

   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.

   Z-1480-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported Oncomine Dx Target Test problems

Oncomine Dx Target Test models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Oncomine™ Dx Target Test A32441

  Next generation sequencing oncology panel, somatic or germline variant detection system
  1 recall1 report
• Oncomine™ Dx Target Test A32441

  Next generation sequencing oncology panel, somatic or germline variant detection system
  1 recall0 reports

Recent Oncomine Dx Target Test adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2018False Negative Result; Incorrect Or Inadequate Test Results; False Negative Result; Incorrect Or Inadequate Test Results

  AN INTERNAL INVESTIGATION OF THE ONCOMINE DX TARGET TEST RNA/DNA PANEL (LOT# 1705001), A COMPONENT OF THE ONCOMINE DX TARGET TEST, REVEALED A MANUFACTURING ERROR CAUSED A LOW OLIGONUCLEOTIDE CONCENTRATION IN THE RNA PANEL OF THE FINAL PRODUCT. THE LOW OLIGONUCLEOTIDE CONCENTRATION MAY CAUSE THE ONCOMINE DX TARGET TEST TO MALFUNCTION AND PRODUCE NO TEST RESULTS, OR FALSE NEGATIVE TEST RESULTS TO BE REPORTED TO A CLINICIAN WHEN THE ONCOMINE DX TARGET TEST IS BEING USED TO DETERMINE THE PRESENCE OF A ROS1 GENE VARIANT IN PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC). NSCLC PATIENTS IDENTIFIED WITH A ROS1 GENE VARIANT MAY BE CANDIDATES FOR THE DRUG XALKORI (CRIZOTINIB). CLINICAL STUDIES FOR XALKORI SHOWED THAT 66% OF THE STUDY PARTICIPANTS WITH NSCLC THAT HAD SPREAD TO OTHER PARTS OF THE BODY EXPERIENCED LESSENED METASTASIS, SHRUNKEN TUMORS, OR NO SIGNS OF CANCER. INDIVIDUALS WHO WERE GIVEN XALKORI ALSO HAD A MEDIAN TIME PERIOD OF 18.3 MONTHS BEFORE NOTICABLE TUMOR GROWTH/METASTASIS OCCURED. A FALSE NEGATIVE TEST RESULT FOR A ROS1 VARIANT MAY EXCLUDE A PATIENT FROM RECEIVING XALKORI AND THE POSSIBLE THERAPEUTIC BENEFITS OF THE DRUG. THE PRODUCT MALFUNCTION WAS DISCOVERED INTERNALLY.

  Patient problems: No Patient Involvement

  MAUDE report 7293259 ↗