TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequenc
Summary
The FDA issued a Class III for TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique by Cytocell Ltd.. Reason: May show unexpected locus specific signals in addition to those at 14q32..
Details
Source
Device Recall
External ID
Z-0814-2022
Action Date
2022-03-30
Status
Terminated
Category
device
Product Description
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Lot/Code Info: Lot 074612
Quantity Affected: 1 unit
Reason for Recall
May show unexpected locus specific signals in addition to those at 14q32.
Distribution
MN
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-04
Company
Cambridge, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 146 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0814-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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