FDA recall Z-1099-2021

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-12-22

Report date

2021-02-17

Termination date

2022-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2021