Cytocell Ltd.: Medical Device Recall in 2021 - (Recall #: Z-1099-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 22, 2020

Date Posted: February 17, 2021

Recall Number: Z-1099-2021

Event ID: 87090

Reason for Recall:

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.

Status: Terminated

Product Quantity: 72

Code Information:

Lots 072240, 071390, and 072693

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated