FDAClass IIApril 10, 2024

Torrent Suite Dx Software versions 5.14 and earlier recall: Software Issue

Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic…

Why was Torrent Suite Dx Software versions 5.14 and earlier recalled?

Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument

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: 10190302017848;10190302016810 Torrent Suite Dx Software versions 5.14 and earlier

Product
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic…
Recalling firm
Life Technologies Corporation
Quantity
28 units
Distribution
US Nationwide distribution in the states of CA, IN, NC OR, TN.
Recall date
April 10, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls