RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating
Summary
The FDA issued a Class II for RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laborat by Cytocell Ltd.. Reason: DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing..
Details
Source
Device Recall
External ID
Z-2209-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Lot/Code Info: Catalog No. LPS508-A; UDI-DI: 05055844900509; Lot No. 076763, 077253, 080125, 080763, 082128, 083041, 083246, 083555.
Quantity Affected: 60 units
Reason for Recall
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Distribution
US Nationwide distribution in the states of CA, FL, OH, & SC.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-24
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 192 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-2209-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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