Class 3 Device Recall Aquarius D13S319 Plus Deletion Probe

• Date Initiated by Firm: April 26, 2019
• Date Posted: June 19, 2019
• Recall Status: Terminated on July 16, 2020
• Recall Number: Z-1843-2019
• Recall Event ID: 82917
• Product Classification: Reagents, specific, analyte - Product Code MVU
• Product: Aquarius D13S319 Plus Deletion Probe, Model LPH068-A; ; Product Usage:; The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe.
• Code Information: Lot Numbers: 058585, 061111, 061354, 062527
• Recalling Firm/ Manufacturer: Cytocell Ltd.; 418 Cambridge Science Park, Milton Road; Oxford Gene Technology; Cambridge United Kingdom
• Manufacturer Reason for Recall: There is an error in the chromomap on the package insert.
• FDA Determined Cause: Labeling False and Misleading
• Action: Urgent Medical Device Recall letters were distributed to customers beginning 4/26/19.
• Quantity in Commerce: 400
• Distribution: Worldwide Distribution - US Nationwide AL, CO, FL, HI, IA, IL, IN, KY, MA, MD, MI, MO, MS, NC, NJ, NY, TN, TX, UT, WA, and WI. The products were distributed to the following foreign countries: 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.