CytoCell BCL11B Proximal in FITC Spectrum-LDT for recall: Labeling Error
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering…
Why was CytoCell BCL11B Proximal in FITC Spectrum-LDT for 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot RD22/230/10
- Product
- CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering…
- Recalling firm
- Cytocell Ltd.
- Distribution
- TX
- Recall date
- December 7, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)