Oncomine™ Dx Target Test A32441 (UDI 10190302006385)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190302006385), 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).

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (P160045); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 problems

Recent adverse event reports

The 1 most recent of 1 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160045. One submission often covers many models, so check the product and lot details in each record.

• Z-1704-2020 · Mar 16, 2020 · Terminated
  Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.
• Z-1705-2020 · Mar 16, 2020 · Terminated
  Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443
• Z-1707-2020 · Mar 16, 2020 · Terminated
  Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
• Z-1706-2020 · Mar 16, 2020 · Terminated
  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
• Z-1279-2018 · Dec 4, 2017 · Terminated
  Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in