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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 FirmJuly 17, 2020
Create DateAugust 20, 2020
Recall Status1 Terminated 3 on September 30, 2020
Recall NumberZ-2829-2020
Recall Event ID 86084
Product Classification Reagents, specific, analyte - Product Code MVU
ProductCytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.
Code Information Lot numbers: 069915, 070433, 069305, 069468
FEI Number 3002646096
Recalling Firm/
Manufacturer		 Cytocell Ltd.
418 Cambridge Science Park, Milton Road
Oxford Gene Technology
Cambridge United Kingdom
Manufacturer Reason
for Recall		A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
FDA Determined
Cause 2		Under Investigation by firm
ActionCytocell issued Urgent Medical Device Recall Letter dated July 17,200 stating 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. Please complete and return the enclosed response form as soon as possible. We wish to sincerely apologise for any inconvenience caused as a result of this medical device recall. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com.
Quantity in Commerce62 units
DistributionWorldwide distribution - US Nationwide distribution and the country of Canada.
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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