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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 May 27, 2021
Create Date August 18, 2021
Recall Status1 Terminated 3 on May 09, 2022
Recall Number Z-2323-2021
Recall Event ID 88294
Product Classification Reagents, specific, analyte - Product Code MVU
Product Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Code Information Lots 073004 and 072518 (Probe lot 200918-006).
Recalling Firm/
Manufacturer		 Cytocell Ltd.
418 Cambridge Science Park, Milton Road
Oxford Gene Technology
Cambridge United Kingdom
Manufacturer Reason
for Recall		 May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Cytocell issued Urgent Medical Device Recall Users issued via email on 5/27/21. Letter states reason for recall, heath 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 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 9q34. 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 23 units
Distribution US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
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.
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