Home / Recalls / Cytocell Ltd. / Z-0824-2022

Z-0824-2022 Class III Terminated

Recalled by Cytocell Ltd. — Cambridge, N/A

FDA device recall Z-0824-2022 was initiated by Cytocell Ltd. on February 14, 2022 and is designated Class III. Reason for recall: Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the… The recall status is terminated (terminated June 12, 2023). Affected quantity: 5 kits.

Recall Details

Product Type
Devices
Report Date
March 30, 2022
Initiation Date
February 14, 2022
Termination Date
June 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 kits

Product Description

Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

Reason for Recall

Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.

Distribution Pattern

US Nationwide distribution in the states of CT, TX.

Code Information

Lot 210511-018

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-0341-2023 Class II — CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD (October 27, 2022)
  • Z-0353-2023 Class II — CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related m (October 27, 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-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