PlainRecalls
FDA Devices Moderate Class II Terminated

CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

Reported: December 7, 2022 Initiated: October 27, 2022 #Z-0341-2023

Product Description

CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

Reason for Recall

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.

Details

Recalling Firm
Cytocell Ltd.
Units Affected
3 units
Distribution
TX
Location
Cambridge

Frequently Asked Questions

What product was recalled?
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782. Recalled by Cytocell Ltd.. Units affected: 3 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 7, 2022. Severity: Moderate. Recall number: Z-0341-2023.