Home / Recalls / Cytocell Ltd. / Z-2134-2021

Z-2134-2021 Class II Terminated

Recalled by Cytocell Ltd. — Cambridge, N/A

Recall Details

Product Type
Devices
Report Date
August 4, 2021
Initiation Date
May 17, 2021
Termination Date
August 15, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50

Product Description

CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics

Reason for Recall

The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.

Distribution Pattern

Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.

Code Information

Lot Numbers: 071399 072985

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