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U.S. Department of Health and Human Services

Class 3 Device Recall Breakapart Probe

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 Class 3 Device Recall Breakapart Probesee related information
Date Initiated by FirmFebruary 04, 2022
Create DateMarch 21, 2022
Recall Status1 Terminated 3 on November 06, 2024
Recall NumberZ-0814-2022
Recall Event ID 89669
Product Classification Reagents, specific, analyte - Product Code MVU
Product TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Code Information Lot 074612
Recalling Firm/
Manufacturer		 Cytocell Ltd.
418 Cambridge Science Park, Milton Road
Oxford Gene Technology
Cambridge United Kingdom
Manufacturer Reason
for Recall		May show unexpected locus specific signals in addition to those at 14q32.
FDA Determined
Cause 2		Under Investigation by firm
ActionCytocell issued Urgent Medical Device Recall letter (VC/2022/005) to Distributor/End User via email on 2/4/22 . 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 you destroy the remaining inventory. We also suggest that laboratories undertake a review of the results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signals at 9q34. 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.
Quantity in Commerce1 unit
DistributionMN
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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