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U.S. Department of Health and Human Services

Class 3 Device Recall Cytocell

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  Class 3 Device Recall Cytocell see related information
Date Initiated by Firm February 14, 2022
Create Date March 24, 2022
Recall Status1 Open3, Classified
Recall Number Z-0824-2022
Recall Event ID 89747
Product Classification General purpose reagent - Product Code PPM
Product Cytocell 8 Square Template Slides (Glass)- microscope slides
Reference: PCN008
Code Information Lot 210511-018
Recalling Firm/
Manufacturer		 Cytocell Ltd.
418 Cambridge Science Park, Milton Road
Oxford Gene Technology
Cambridge United Kingdom
Manufacturer Reason
for Recall		 Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.
FDA Determined
Cause 2		 Under Investigation by firm
Action Cytocell issued Urgent Medical Device Recall dated 2/14/22 via email. The 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. 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 5 kits
Distribution US Nationwide distribution in the states of CT, TX.
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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