Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML o
Summary
The FDA issued a Class II for Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chro by Cytocell Ltd.. Reason: individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. T.
Details
Source
Device Recall
External ID
Z-0741-2022
Action Date
2022-03-16
Status
Terminated
Category
device
Product Description
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Lot/Code Info: Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711
Quantity Affected: 19 kits
Reason for Recall
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
Distribution
US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-18
Company
Cambridge, N/A
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 143 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-0741-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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