Cytocell Ltd. recalls Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb…

Recall date

April 26, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1843-2019

FDA classification

Class III

Brand / firm

Cytocell Ltd.

Sold / distributed

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.

Why it was recalled

There is an error in the chromomap on the package insert.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.