CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Summary
The FDA issued a Class II for CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD by Cytocell Ltd.. Reason: 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 th.
Details
Source
Device Recall
External ID
Z-0341-2023
Action Date
2022-12-07
Status
Terminated
Category
device
Product Description
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Lot/Code Info: Lot Number: RD22/230/11
Quantity Affected: 3 units
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.
Distribution
TX
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-27
Company
Cambridge
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cytocell Ltd. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cytocell Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cytocell Ltd. have FDA actions?
Cytocell Ltd. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0341-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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