Class 2 Device Recall DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe

• Date Initiated by Firm: May 17, 2021
• Create Date: July 23, 2021
• Recall Status: Terminated on August 15, 2022
• Recall Number: Z-2134-2021
• Recall Event ID: 88138
• Product Classification: Reagents, specific, analyte - Product Code MVU
• Product: CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
• Code Information: Lot Numbers: 071399 072985
• FEI Number: 3002646096
• Recalling Firm/ Manufacturer: Cytocell Ltd.; 418 Cambridge Science Park, Milton Road; Oxford Gene Technology; Cambridge United Kingdom
• Manufacturer Reason for Recall: The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An Urgent Medical Device Recall notification letter dated 5/17/21 was sent to customers. Actions to be taken by [Customer/User] 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 any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signal at 20p12/13. Corrective and Preventative Actions: Cytocell are currently investigating how this issue occurred and will be implementing the necessary corrective and preventative actions to reduce the risk of recurrence. Your assistance is appreciated and necessary to ensure the interpretation of a result from a resulting LDT is not affected. 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 Commerce: 50
• Distribution: Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.
• 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.