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.
FDA Recall Z-1843-2019 · Posted 2019-06-19
Recalling FirmCytocell Ltd.
Recall StatusTerminated
Product CodeMVU
Date Initiated2019-04-26
Date Terminated2020-07-16
Product Quantity400
Reason for Recall
There is an error in the chromomap on the package insert.
Firm Action
Urgent Medical Device Recall letters were distributed to customers beginning 4/26/19.
Root Cause
Labeling False and Misleading
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.