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

Z-2323-2021 Class II Terminated

Recalled by Cytocell Ltd. — Cambridge, N/A

FDA device recall Z-2323-2021 was initiated by Cytocell Ltd. on May 27, 2021 and is designated Class II. 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 The recall status is terminated (terminated May 9, 2022). Affected quantity: 23 units.

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).

Other recalls by Cytocell Ltd.

  • Z-2209-2023 Class II — RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laborat (May 24, 2023)
  • Z-2210-2023 Class II — RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laborator (May 24, 2023)
  • Z-0353-2023 Class II — CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related m (October 27, 2022)
  • Z-0341-2023 Class II — CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD (October 27, 2022)
  • Z-0824-2022 Class III — Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 (February 14, 2022)
  • Z-0814-2022 Class III — TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique (February 4, 2022)
  • 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)
  • Z-1493-2021 Class II — Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific (March 19, 2021)
  • Z-1099-2021 Class II — Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Di (December 22, 2020)

FDA data resources