Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related Recalled by Cytocell Ltd. Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cytocell Ltd. directly.
Affected Products
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
Why Was This Recalled?
Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert
Where Was This Sold?
This product was distributed to 1 state: TX
About Cytocell Ltd.
Cytocell Ltd. has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report