Home / Recalls / Cytocell Ltd. / Z-1202-2019

Z-1202-2019 Class III Terminated

Recalled by Cytocell Ltd. — Adderbury Banbury Oxfordshire, N/A

Recall Details

Product Type
Devices
Report Date
May 1, 2019
Initiation Date
March 15, 2019
Termination Date
October 13, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19

Product Description

Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

Reason for Recall

There is an error in the chromomap included in the labeling for the product.

Distribution Pattern

The products were distributed to the following US states: IL, TN.

Code Information

Lot numbers: 056996 061156 062616 062808

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  • 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)
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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-2323-2021 Class II — Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte speci (May 27, 2021)
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  • Z-1493-2021 Class II — Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific (March 19, 2021)