Home / Recalls / Cytocell Ltd. / Z-2323-2021

Z-2323-2021 Class II Terminated

Recalled by Cytocell Ltd. — Cambridge, N/A

Recall Details

Product Type
Devices
Report Date
August 25, 2021
Initiation Date
May 27, 2021
Termination Date
May 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23 units

Product Description

Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

Reason for Recall

May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34

Distribution Pattern

US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.

Code Information

Lots 073004 and 072518 (Probe lot 200918-006).

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  • Z-0741-2022 Class II — Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chro (January 18, 2022)
  • Z-2134-2021 Class II — CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU0 (May 17, 2021)
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