BCL11B Diagnostic Reagent Recalled for Chromomap Documentation Error
Cytocell Ltd. is recalling a diagnostic reagent due to an error in the chromomap on the package insert. The nucleotide locations in the text are correct, but the chromosome map was created using incorrect coordinates.
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 labeling and documentation error with no reported illnesses or injuries. The correct nucleotide locations are available in the insert text; only the visual chromomap contains incorrect coordinates. Per the severity rubric, minor labeling errors without reported harm are classified as Moderate.
Plain-English summary
Cytocell Ltd. is recalling the CytoCell BCL11B Distal in Texas Red Spectrum Analyte Specific Reagent (Lot Number RD22/230/11) distributed in Texas. The product is used in diagnostic cytogenetic testing.
The package insert contains an error in the chromomap (chromosome map) on version 1. While the nucleotide locations specified in the text of the insert are correct, the chromomap visual representation was created using incorrect coordinates. This discrepancy could lead to confusion when interpreting test results.
Healthcare providers and laboratories using this lot should verify the correct nucleotide locations from the insert text rather than relying on the chromomap. Contact Cytocell Ltd. for information about obtaining a corrected package insert or a replacement product.
The recalled product
- Product
- CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
- Manufacturer
- Cytocell Ltd.
- Hazard
- labeling-error
- documentation-error
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 Number: RD22/230/11
Distribution
Distributed in 1 state:
- TX
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