Oncomine™ Dx Target Test A32441 (UDI 10190302015103)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 16, 2020Terminated

   Extended Expiration Date prior to clearance

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

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-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-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-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-1480-2018 · Feb 8, 2018 · Terminated
  Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
• 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