Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Summary
The FDA issued a Class II for Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte speci by Cytocell Ltd.. Reason: May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34.
Details
Source
Device Recall
External ID
Z-2323-2021
Action Date
2021-08-25
Status
Terminated
Category
device
Product Description
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Lot/Code Info: Lots 073004 and 072518 (Probe lot 200918-006).
Quantity Affected: 23 units
Reason for Recall
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Distribution
US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-27
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 221 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-2323-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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