FDA Device Intelligence
Home › Device types › OYX

Bcr/Abl1 Monitoring Test

FDA product code OYX · Class 2 · Medical Genetics

3
Registered devices
6
Adverse events
3
Recalls
6
510(k) clearances

Devices with this code

QuantideX qPCR BCR-ABL IS Kit — ASURAGEN, INC.MRDx BCR-ABL Test — MOLECULARMD CORP.Xpert BCR-ABL Ultra — CEPHEID

Recent recalls

DateFirmReason
2025-10-30CepheidInvitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
2025-10-30CepheidInvitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
2024-02-15Bio-Rad LaboratoriesDue to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.