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Recall Observatory FDA recall evidence

Device 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

Z-1099-2021

December 22, 2020

Class II

Product summary

Firm
Cytocell Ltd.
Event
Event 87090
Status
Terminated
Classification
Class II
Quantity
72
Official record key
device-enforcement:Z-1099-2021

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.