Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples
Summary
The FDA issued a Class II for Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid t by Biocartis Nv. Reason: False-positive MSI-H results generated by the Idylla MSI Test..
Details
Source
Device Recall
External ID
Z-0836-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
Lot/Code Info: UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.
Quantity Affected: 8 units
Reason for Recall
False-positive MSI-H results generated by the Idylla MSI Test.
Distribution
US: AL, NJ, TX, OH, CA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-10
Company
Mechelen
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 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Biocartis Nv has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 (Biocartis Nv) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biocartis Nv have FDA actions?
Biocartis Nv has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0836-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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