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U.S. Department of Health and Human Services

Class 2 Device Recall Cytocell

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 Class 2 Device Recall Cytocellsee related information
Date Initiated by FirmOctober 27, 2022
Date PostedDecember 01, 2022
Recall Status1 Terminated 3 on December 27, 2024
Recall NumberZ-0353-2023
Recall Event ID 91117
Product Classification Reagents, specific, analyte - Product Code MVU
ProductCytoCell 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
Code Information Lot RD22/230/10
FEI Number 3002646096
Recalling Firm/
Manufacturer		 Cytocell Ltd.
418 Cambridge Science Park, Milton Road
Oxford Gene Technology
Cambridge United Kingdom
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Under Investigation by firm
ActionCytocell issued Urgent Medical Device Recall letter on 10/27/22 to the end-user via email. Letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert. Once implemented, all devices can continue to be used as the device itself has not malfunctioned. Please complete and return the enclosed response form as soon as possible. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com.
DistributionTX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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