FDA recall Z-2134-2021

Product

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

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

Key facts

Status

Terminated

Initiation date

2021-05-17

Report date

2021-08-04

Termination date

2022-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2134-2021