Class 3 Device Recall Cytocell

• Date Initiated by Firm: February 14, 2022
• Create Date: March 24, 2022
• Recall Status: Terminated on June 12, 2023
• 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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.