Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aquarius LPH 511-A CRLF2 Distal Probe Green Recalled by Cytocell Ltd. Due to Users may observe very faint additional locus specific...

Date: December 22, 2020
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 LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene

Quantity: 72

Why Was This Recalled?

Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.

Where Was This Sold?

Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.

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