Idylla INSTRUMENT recall
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable…
Why was Idylla INSTRUMENT recalled?
False-positive MSI-H results generated by the Idylla MSI Test.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.
- Product
- Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable…
- Recalling firm
- Biocartis Nv
- Quantity
- 8 units
- Distribution
- US: AL, NJ, TX, OH, CA
- Recall date
- January 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)