Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0341-2023 — CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

U.S. FDA — Device Enforcement · United Kingdom · 2022-10-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0341-2023
Date of alert
2022-10-27
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Cytocell Ltd.
Product category
device
Product type
Devices
Reported risk: An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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