TCL1 Breakapart Probe May Display Unexpected Genetic Signals
Cytocell Ltd. is recalling TCL1 Breakapart FISH probes (Lot 074612) because the diagnostic test may show unexpected signals beyond the intended chromosome target.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III medical device recall with no reported illnesses or injuries. The issue involves diagnostic test accuracy, which could affect patient care decisions, but the hazard is theoretical with no documented patient harm.
Plain-English summary
Cytocell Ltd. has recalled TCL1 Breakapart Probe (Catalog Number LPH046-A, Lot 074612), a diagnostic device used in fluorescence in situ hybridization (FISH) testing to identify chromosomal abnormalities.
The probe may display unexpected locus-specific signals in addition to those at the intended target location (14q32). This diagnostic inaccuracy could affect test interpretation and potentially lead to misdiagnosis.
The affected product was distributed in Minnesota. Healthcare providers and laboratory personnel using this lot should be aware of the potential for unexpected signals when performing TCL1 FISH testing and should take appropriate quality control measures.
The recalled product
- Product
- TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
- Manufacturer
- Cytocell Ltd.
- Hazard
- unexpected-signals
- diagnostic-error
- test-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 074612
Distribution
Distributed in 1 state:
- MN
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