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.
- Recall Initiated
- April 26, 2019
- Posted
- June 19, 2019
- Terminated
- July 16, 2020
- Recall Number
- Z-1843-2019
- Quantity
- 400
Reason for Recall
There is an error in the chromomap on the package insert.
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.
Lot / Code Info
Lot Numbers: 058585, 061111, 061354, 062527
Root Cause
Labeling False and Misleading
Action Taken
Urgent Medical Device Recall letters were distributed to customers beginning 4/26/19.
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