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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chronic lymphocytic leukemia fish probe kit
Definition The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information.
Product CodeOVQ
Regulation Number 866.6040
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MOLECULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Sep-27-2021
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