Home / Recalls / Cytocell Ltd. / Z-1099-2021

Z-1099-2021 Class II Terminated

Recalled by Cytocell Ltd. — Cambridge, N/A

Recall Details

Product Type
Devices
Report Date
February 17, 2021
Initiation Date
December 22, 2020
Termination Date
June 7, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
72

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

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 Pattern

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

Code Information

Lots 072240, 071390, and 072693

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