Cytocell Ltd. recalls Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of…

Recall date

December 22, 2020

Source

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

Recall number

Z-1099-2021

FDA classification

Class II

Brand / firm

Cytocell Ltd.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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