Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Aquarius D13S319 Plus Deletion Probe Recalled by Cytocell Ltd. Due to There is an error in the chromomap on...

Date: April 26, 2019
Company: Cytocell Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cytocell Ltd. directly.

Affected Products

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.

Quantity: 400

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cytocell Ltd.

Cytocell Ltd. has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report