Class 2 Device Recall Chromosome X AlphaSatellite in FITC Spectrum

• Date Initiated by Firm: March 19, 2021
• Create Date: April 26, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1493-2021
• Recall Event ID: 87621
• Product Classification: Reagents, specific, analyte - Product Code MVU
• Product: Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
• Code Information: Lot: RD20/253/16, RD21/043/01, RD21/043/02
• Recalling Firm/ Manufacturer: Cytocell Ltd.; 418 Cambridge Science Park, Milton Road; Oxford Gene Technology; Cambridge United Kingdom
• For Additional Information Contact: Aysel Parr Heckel; 914-467-5285
• Manufacturer Reason for Recall: Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
• FDA Determined Cause: Under Investigation by firm
• Action: On 3/19/2021, Cytocell issued an Urgent Medical Device Recall notice via email notifying customers they may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
• Quantity in Commerce: 89 probes
• Distribution: US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.
• 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.