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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 Cytocell see related information
Date Initiated by Firm January 18, 2022
Create Date March 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-0741-2022
Recall Event ID 89602
Product Classification FISH based detection of chromosomal abnormalities from patients with hematologic malignancies - Product Code QDI
Product Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS
Catalog Number: USA-LPH024
Code Information Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711
Recalling Firm/
Manufacturer		 Cytocell Ltd.
418 Cambridge Science Park, Milton Road
Oxford Gene Technology
Cambridge United Kingdom
Manufacturer Reason
for Recall		 individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action Cytocell issued Urgent Medical Recall Reference: VC/2022/001 letter on 1/18/22 to Distributors and End Users 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 you destroy the remaining inventory. We also suggest that laboratories undertake a review of any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of the probe being manufactured with the fluorophores the incorrect way around. 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 Commerce 19 kits
Distribution US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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