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Medical Genetics devices

6 product codes reviewed by the Medical Genetics panel. 17 510(k) clearances and 4 recalls in the FDA data, 50% of those recalls name a 510(k).

1510(k)s in 12 months
2recalls in 12 months
2recalls that name a 510(k)

Codes with the most recalls

CodeDeviceAll time12 months
OYXBcr/Abl1 Monitoring Test32
QDIFish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies10

Active product codes

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
OYXBcr/Abl1 Monitoring Test212

Latest recalls in this panel

DateFirm and productCodeLinked 510(k)
Dec 18, 2025Cepheid
Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Open, Classified		 OYXNone listed
Dec 18, 2025Cepheid
Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Open, Classified		 OYXK190076
Mar 22, 2024Bio-Rad Laboratories
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Open, Classified		 OYXK181661
Jan 18, 2022Cytocell Ltd.
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Terminated		 QDINone listed

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