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Z-2134-2021 Class II Terminated

Recalled by Cytocell Ltd. — Cambridge, N/A

FDA device recall Z-2134-2021 was initiated by Cytocell Ltd. on May 17, 2021 and is designated Class II. 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. The recall status is terminated (terminated August 15, 2022). Affected quantity: 50.

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

Other recalls by Cytocell Ltd.

  • Z-2210-2023 Class II — RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laborator (May 24, 2023)
  • Z-2209-2023 Class II — RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laborat (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-2323-2021 Class II — Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte speci (May 27, 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