medical Class II Updated 2021-02-17

Cytocell Ltd. recalls Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 5

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.
Lot/Code Info: Lots 072240, 071390, and 072693
View official government recall

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