Laboratory Diagnostic Probe Recalled for Incorrect Chromosome Map Labeling
Cytocell Ltd. recalls CytoCell BCL11B Proximal probe used in T-cell malignancy testing (lot RD22/230/10). The package insert contains an incorrect chromosome map that doesn't match the probe design.
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 an FDA Class II recall involving a labeling error in the package insert. No illnesses, injuries, or hospitalizations are reported. The hazard involves a documentation mismatch without confirmed clinical consequences, fitting the definition of a minor labeling error.
Plain-English summary
Cytocell Ltd. is recalling CytoCell BCL11B Proximal in FITC Spectrum-LDT, an analyte-specific reagent probe used to detect T-cell related malignancy. Lot RD22/230/10 is affected.
The device's package insert contains a labeling error. Specifically, the chromomap (a visual diagram showing where the probe maps to on chromosome 14q32.2) in version 1 of the package insert is incorrect and does not match the probe design and specifications documented elsewhere in the same package insert.
The device was distributed in Texas. Healthcare providers and laboratory operators with the recalled lot should verify the probe specifications against the package insert and contact Cytocell Ltd. if they have questions about the chromomap or the probe design. Any adverse events should be reported to the FDA.
The recalled product
- Product
- CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781
- Manufacturer
- Cytocell Ltd.
- Hazard
- mis-labeling
- 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 RD22/230/10
Distribution
Distributed in 1 state:
- TX
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