Cytocell Ltd.: Medical Device Recall in 2019 - (Recall #: Z-1843-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: April 26, 2019

Date Posted: June 26, 2019

Recall Number: Z-1843-2019

Event ID: 82917

Reason for Recall:

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

Status: Terminated

Product Quantity: 400

Code Information:

Lot Numbers: 058585, 061111, 061354, 062527

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.

Voluntary or Mandated:

Voluntary: Firm initiated